Evidence review for psychological therapies

National Guideline Centre (UK)

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Evidence review for psychological therapies

Tinnitus: assessment and management

Evidence review L

NICE Guideline, No. 155

Authors

National Guideline Centre (UK).

London: National Institute for Health and Care Excellence (NICE); 2020 Mar.

ISBN-13: 978-1-4731-3711-0

1. Psychological therapies

1.1. Review question: What is the clinical and cost effectiveness of psychological therapies (including cognitive behavioural therapy and mindfulness based cognitive therapy)?

1.2. Introduction

While tinnitus is recognised as a physical symptom it is understood that it can have a profound emotional impact and that this is a major factor in the degree of suffering experienced.

There are a variety of different psychological therapies available currently within the NHS as interventions for a broad range of presentations. The following therapies have been applied either clinically or within a research context for people with tinnitus: cognitive behavioural therapy (CBT), mindfulness-based interventions e.g. mindfulness based cognitive therapy (MBCT) and mindfulness based stress reduction (MBSR), brief solution focused therapy, narrative therapy, acceptance and commitment therapy (ACT) and Eye Movement Desensitisation and Reprocessing (EMDR). These psychological therapies can be used with adults and can also be adapted for use with children and young people. Current practice includes psychological therapies within individual and group settings. When working with children, this often involves also working with their families and possibly schools.

CBT has been the main focus clinically and within research. Cognitive Behaviour Therapy (CBT) is based on the theory that an individual’s distress arises out of an interaction between their environment and past experiences, thoughts (cognitions), behaviour and physiological experiences.

The aim of this review is to determine the clinical and cost-effectiveness of psychological therapies including cognitive behavioural therapy and mindfulness based cognitive therapy in improving psychological outcomes and the impact of tinnitus on the person.

1.3. PICO table

For full details see the review protocol in appendix A.

1.4. Clinical evidence

1.4.1. Included studies

Twenty-four studies were included in the review;¹^, ⁵^–⁷^, ⁹^, ¹⁶^, ¹⁹^, ²¹^, ²²^, ²⁶^, ³¹^, ³³^–³⁵^, ³⁹^, ⁴⁶^, ⁵⁰^, ⁵²^, ⁵³^, ⁵⁵^, ⁵⁹^, ⁶⁰^, ⁶²^, ⁶⁴ these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix H.

1.4.2. Excluded studies

See the excluded studies list in appendix I.

1.4.3. Summary of clinical studies included in the evidence review

See appendix D for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Cognitive behavioural therapy (CBT)

Mindfulness-based therapies

Acceptance and commitment therapy (ACT)

See appendix F for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

One health economic study was identified with the relevant comparison and has been included in this review.³⁷ This is summarised in the health economic evidence profile below (Table 4) and the health economic evidence table in appendix H.

1.5.2. Excluded studies

Two economic studies relating to this review question were identified but were excluded due to methodological limitations. These are listed in appendix I, with reasons for exclusion given.

See also the health economic study selection flow chart in appendix G.

1.5.3. Summary of studies included in the economic evidence review

1.5.4. Health economic modelling

In order to explore the most cost-effective method of delivering psychological therapy for people who have tinnitus related distress, a threshold analysis was conducted.

Methods and inputs

The committee specified some typical psychological interventions to be evaluated. These interventions were selected on the basis that they had demonstrated evidence of clinical effectiveness in the literature. These are described in Table 28 and Table 29. The main NHS resource use involved in these interventions is staff time and this was costed using a standard national source ¹⁸ – see Table 30. Using this information, costs per patient for each intervention have been calculated – see Table 31.

The results from Table 31 demonstrated that digital CBT is the least expensive intervention and individual CBT is the most expensive intervention. However, the committee reported that in current practice, a proportion of people with tinnitus, after an initial psychological intervention, will need to be stepped to a second-line psychological intervention. Table 32 lists the proportion of individuals that would need to be stepped up from a hypothetical population of 1000 people with tinnitus.

Threshold analysis – base case results

Interventions are generally considered cost-effective if they cost less than £20,000 per QALY gained. The QALYs gained that would be required for an intervention to be cost effective at this threshold compared with no psychological intervention was calculated. Table 33 presents the costs of delivering psychological interventions while taking into consideration that a number of people with tinnitus will need to be stepped to second line intervention (see Table 32). Table 33 also presents the incremental QALYs that need to be generated for a particular psychological strategy to be cost-effective. The method used to calculate the incremental QALYs required was as follows:

ICER (incremental cost-effectiveness ratio) = Incremental costs ÷ Incremental QALY
Therefore: Incremental QALYs = Incremental costs ÷ ICER
At the threshold of cost effectiveness the ICER=20,000 per QALY and so
Incremental QALYs=Incremental cost ÷ 20,000.

Alongside the study by Maes(2014) study, the committee also requested that they be presented with QALY gains from RCTs exploring the clinical effectiveness of psychological interventions to help people with chronic pain. This population was chosen because the committee were of the view that the way people experience symptoms of chronic pain are similar to the experiences people have with tinnitus. The relevant studies selected and the QALY gains achieved in those studies by the respective psychological intervention are listed in Table 34.

In order to consider how sensitive the costs were in relation to the proportion of people that require an additional intervention, a sensitivity analysis was conducted. In the sensitivity analysis the proportion requiring an additional intervention was adjusted from 0% - 100%. The results are presented in Figure 1 which also highlights the base case assumptions (denoted as a diamond on each line), that is, how many people will be stepped to a second line intervention as described in Table 32. There is also a dotted line to illustrate the cost of the least expensive strategy in the base case.

1.6. Evidence statements

1.6.1. Clinical evidence statements

Cognitive behavioural therapy

CBT versus waiting-list control

Four studies (n=173) were included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance and general quality of life. There was a clinical benefit of CBT for the outcomes tinnitus distress (at longer follow-up), tinnitus-related quality of life (post-treatment), anxiety (measured using the VAS). There was no clinical difference between CBT and waiting-list control for the outcomes tinnitus severity, tinnitus distress (post-treatment), tinnitus loudness, tinnitus annoyance, depression, anxiety (measured using the HADS) and sleep disturbance. The overall quality of the evidence was Very Low to Low due to risk of bias, inconsistency and imprecision.

CBT versus control (masking)

One study (n=100) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, health-related quality of life, tinnitus-related quality of life and tinnitus annoyance. There was a clinical benefit of CBT for the outcome of tinnitus severity. There was no clinical difference between CBT and masking for the outcomes of depression and anxiety. The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

CBT versus information only

One study (n=105) were included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, general quality of life, tinnitus annoyance and tinnitus-related quality of life. There was no clinical difference between CBT and information only for the outcomes of tinnitus distress and depression. The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

CBT versus education

Three studies (n=163) were included in this comparison; no clinical evidence was reported for the critical outcome: health-related quality of life. There was clinical benefit of CBT for the outcomes tinnitus distress (post-treatment), tinnitus-related quality of life (post-treatment) and tinnitus annoyance (at a longer follow-up). There was no clinical difference between CBT and education for the outcomes tinnitus distress (at a longer follow-up), tinnitus-related quality of life (at a longer follow-up), tinnitus annoyance (post-treatment), tinnitus loudness ad depression. The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

CBT versus relaxation

One study (n=59) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was a clinical benefit of CBT for the outcome of depression. There was no clinical difference between CBT and relaxation for the outcomes of tinnitus severity, tinnitus distress and tinnitus loudness. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

CBT versus passive relaxation training

One study (n=18) was included in this comparison; no clinical evidence was reported for the critical outcomes tinnitus severity, general quality of life and tinnitus-related quality of life. There was a clinical benefit of CBT for the outcome of anxiety (measured using the STAI-trait). There was no clinical difference between CBT and passive relaxation training for the outcomes tinnitus annoyance, tinnitus loudness, tinnitus distress, insomnia, depression and anxiety (measured using the STAI-state). The overall quality of the evidence was Very Low due to risk of bias and imprecision.

CBT versus applied relaxation training

One study (n=23) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, general quality of life and tinnitus-related quality of life. There was no clinical difference between CBT and passive relaxation training for the outcomes tinnitus annoyance, tinnitus loudness, tinnitus distress, insomnia, depression and anxiety. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

CBT-stepped intervention versus usual care

One study (n=394) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress and tinnitus annoyance. There was clinical benefit of the CBT-stepped intervention for general quality of life. There was no clinical difference between the CBT-stepped intervention and usual care for the outcomes of tinnitus severity, tinnitus-related quality of life, depression and anxiety. The overall quality of the evidence was Moderate to High due to imprecision.

CBT (self-help book) versus waiting-list control

One study (n=125) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical difference between CBT (self-help books) and waiting-list control for the outcome of tinnitus distress. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

CBT (bibliotherapy) versus information only

One study (n=109) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between CBT (bibliotherapy) and information only for the outcomes of tinnitus distress and depression. The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

CBT versus control (web discussion forum)

One study (n=81) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical benefit of CBT for the outcomes tinnitus severity and tinnitus distress. There was no clinical difference between CBT and the control group for the outcomes depression, anxiety and sleep. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

iCBT versus waiting-list control

One study (n=72) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, tinnitus distress, general quality of life and tinnitus-related quality of life. There was no clinical difference between iCBT and waiting-list control for the outcomes of tinnitus annoyance, tinnitus loudness, depression and anxiety. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

iCBT versus information only

Two study (n=161) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, general quality of life and tinnitus-related quality of life. There was no clinical difference between iCBT and information only for the outcomes of tinnitus distress, tinnitus annoyance, tinnitus loudness, depression, anxiety and sleep. The overall quality of the evidence was Very Low due to risk of bias, inconsistency and imprecision.

iCBT versus tinnitus information counselling

One study (n=88) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance and tinnitus-related quality of life. There was clinical benefit of iCBT for tinnitus severity, tinnitus distress and sleep (at a longer follow-up). There was no clinical difference between iCBT and “tinnitus information counselling” for the outcomes for tinnitus severity, tinnitus distress and sleep (post-treatment), general quality of life, depression and anxiety (when measured post-treatment and a longer follow-up). The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

iCBT versus control (web discussion forum)

One study (n=262) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was a clinical benefit of iCBT for the outcomes tinnitus severity and distress and tinnitus distress. There was no clinical difference between iCBT and the control group for the outcomes quality of life, depression, anxiety and sleep. The overall quality of the evidence was Very Low to Low due to risk of bias and imprecision.

iCBT versus iACT

One study (n=63) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was a clinical benefit of iCBT for the outcome of sleep. There was no clinical difference between iCBT and iACT for the outcomes tinnitus severity and distress, general quality of life, depression and anxiety. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Biofeedback versus waiting-list control

One study (n=42) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between biofeedback and waiting-list control for the outcomes tinnitus distress, general quality of life and tinnitus loudness. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Biofeedback-based CBT versus waiting-list control

One study (n=111) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical benefit of biofeedback-based CBT for the outcome of tinnitus severity (when measured using the TQ). There was no clinical difference between biofeedback-based CBT and waiting-list control for the outcomes tinnitus severity (measured using the Global Severity Index of SLC-90-R), tinnitus distress, tinnitus loudness, depression and sleep. The overall quality of the evidence was Moderate to Low due to risk of bias and imprecision.

Behavioural therapy versus waiting-list control

One study (n=24) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus severity, tinnitus distress, general quality of life and tinnitus-related quality of life. There was no clinical difference between behavioural therapy and waiting-list control for the outcomes tinnitus annoyance, tinnitus loudness and depression. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Mindfulness-based therapies

Mindfulness-based cognitive therapy versus relaxation

One study (n=68) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical benefit of tinnitus severity (when measured using the TFI). There was no clinical difference between mindfulness-based cognitive therapy and relaxation for the outcomes tinnitus severity, tinnitus loudness, depression and anxiety. The overall quality of the evidence was High to Moderate due to risk of bias and imprecision.

Mindfulness meditation versus relaxation therapy

One study (n=61) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between mindfulness meditation and relaxation therapy for the outcomes tinnitus severity, tinnitus loudness, depression and anxiety. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Mindfulness and body-psychotherapy-based group treatment versus waiting-list control

One study (n=31) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, general quality of life and tinnitus-related quality of life. There was clinical benefit of mindfulness and body-psychotherapy-based group treatment for the outcome tinnitus severity (measured using THI) and depression. There was no clinical difference between mindfulness and body-psychotherapy-based group treatment and waiting-list control for the outcomes tinnitus severity (measured using TQ), tinnitus annoyance and tinnitus loudness. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Acceptance and commitment therapy

iACT versus control (web discussion forum)

One study (n=65) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical benefit of iACT for the outcomes tinnitus severity and distress and anxiety. There was no clinical difference between iACT and the control group for the outcomes quality of life, depression and sleep. The overall quality of the evidence was Low to Very Low due to risk of bias and imprecision.

ACT versus waiting-list control

One study (n=44) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was clinical benefit of ACT for the outcomes tinnitus severity. There was no clinical difference between ACT and waiting-list for the outcomes general quality of life, depression, anxiety and sleep. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

1.6.2. Health economic evidence statements

One cost–utility analysis found that a tinnitus pathway which included group stepped CBT approach was cost effective compared with individual consultation with a support worker when appropriate for treating bothersome tinnitus (ICER: £7001 per QALY gained). This analysis was assessed as partially applicable with potentially serious limitations.
One original comparative cost analysis found that
- group therapy stepped up to individual CBT was less costly than individual CBT alone for treating tinnitus (cost saving: £127-£206per patient depending on type of group intervention).
- Internet CBT stepped up to individual CBT was less costly than individual CBT alone for treating tinnitus (cost saving: £102-£194 per patient depending on step-up rate assumed).
- Internet CBT stepped up to individual or group CBT was less costly than individual CBT alone for treating tinnitus (cost saving: £150-£219 per patient depending on step-up rate assumed).
- The results were sensitive to the success rate of the first line therapy

This analysis was assessed as partially applicable (no QALYs) with potentially serious limitations (success rate of first line therapy is highly uncertain).

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

Tinnitus distress, annoyance and tinnitus severity were critical outcomes as they were thought to be common factors for people with tinnitus and impact their quality of life. Quality of life (QoL) (tinnitus-related) general QoL were also critical outcomes due to their impact on the person with tinnitus.

Tinnitus loudness, anxiety, depression, sleep, safety, tolerability and side effects were thought to be important outcomes.

1.7.1.2. The quality of the evidence

Twenty-four randomised controlled trials (RCTs) were included in this review that evaluated psychological therapies for the management of tinnitus in adults. The evidence for this review was centred on cognitive behavioural therapy (CBT), mindfulness-based therapies and acceptance and commitment therapy (ACT). No evidence was identified for the use of psychological therapies in children with tinnitus.

Cognitive behavioural therapy

Different delivery forms of CBT were evaluated within sixteen studies including group CBT sessions, internet-based CBT (iCBT)/digital CBT, provision of CBT self-help book, bibliotherapy (use of CBT manual and CD for progressive muscle relaxation), biofeedback-based CBT and stepped-CBT intervention. These interventions were compared with waiting-list control, provision of information only, education, relaxation, tinnitus information counselling, control group involving a web discussion forum and usual care. Across these comparisons, the outcomes: tinnitus distress, tinnitus severity, general quality of life, tinnitus annoyance, tinnitus loudness, depression, anxiety and sleep were reported. The evidence was graded very low to high due to risk of bias, imprecision and inconsistency.

Mindfulness-based therapies

Three different types of mindfulness-based therapies were evaluated within four studies – mindfulness-based cognitive therapy (MBCT) for tinnitus, mindfulness meditation, mindfulness and body-psychotherapy-based group therapy. These interventions were compared with relaxation (for two of the interventions: mindfulness-based cognitive therapy, mindfulness meditation) or waiting-list control. The only critical outcome reported was tinnitus severity, with the important outcomes of tinnitus loudness, tinnitus annoyance, depression and anxiety reported. The evidence was graded very low to high due to risk of bias and imprecision.

Acceptance and commitment therapy

ACT was evaluated in two studies, which investigated a standard ACT therapy or internet-based ACT. These were compared with a control of a web discussion forum or waiting-list control. Included studies reported outcome data for critical outcomes (tinnitus distress, tinnitus severity and general QoL) and important outcomes (depression, anxiety and sleep). The evidence was graded very low to low due to risk of bias and imprecision.

1.7.1.3. Benefits and harms

Cognitive behavioural therapies

Across a majority of the studies with CBT as the main intervention evaluated, there was clinical benefit of CBT in terms of tinnitus distress and tinnitus severity – two of the critical outcomes for this review. There was no clinical difference between CBT and study comparators in terms of general quality of life, tinnitus annoyance, tinnitus loudness, depression and anxiety and sleep.

CBT is widely used for different presentations but CBT used for the management of tinnitus is tailored in order to make the intervention relevant and useful for people with tinnitus. The guideline committee noted that tinnitus related CBT is not commonly used across the UK; it is currently delivered in specialist tinnitus centres. The most common form of CBT used within current practice is a diluted CBT intervention which uses CBT principles; it is delivered within audiology services in an individual format with limited supervision from psychologists. Whilst digital CBT is unavailable or where it is not suitable, group CBT should be used as the first-line psychological therapy. In current practice, the selection of group-CBT or individual-CBT is made on a case-by-case basis and mainly dependent on the availability of CBT services and individual preferences. The committee noted that some people may be hesitant about group-CBT at first but may find it a more meaningful and positive experience.

Seven studies included in this review evaluated the use of iCBT (also known as digital CBT or internet based CBT) for tinnitus, and showed that it can be effective in reducing tinnitus severity and distress. Internet-based CBT is not currently available in the UK. The committee are however optimistic that it will become available in the UK and predict that the use of digital CBT will start within specialist tinnitus centres and availability will increase over time. This optimism is primarily driven around the successful use of digital CBT for other conditions (e.g. NICE guidelines on depression in adults, CG90) and the committee are of the view that providers, working alongside clinicians with experiences in working with people with tinnitus, will take the initiative to adapt these existing tools for the tinnitus population. There are practical benefits of using digital CBT including that location is less likely to be a limiting factor as it can accessed remotely. Additionally, a more modest time commitment would be required from people with tinnitus. For healthcare professionals, digital CBT can also assist in the triaging of people with tinnitus to appropriate services.

The committee acknowledged the evidence of a CBT stepped intervention which had high quality evidence and showed clinical benefit in terms of tinnitus-related quality of life and general quality of life. The guideline committee noted the importance of tailoring interventions to the individual needs of people with tinnitus, i.e. by using a stepped approach.

Two studies evaluated the use of biofeedback interventions, reporting that some evidence of clinical benefit of biofeedback-based CBT for the outcome tinnitus severity. There was no clinical difference between the biofeedback interventions and waiting-list control for tinnitus distress, quality of life, tinnitus loudness, depression and sleep. The committee discussed that biofeedback is rarely used within current practice; its use is largely limited to behavioural psychology settings.

Mindfulness-based therapies

Mindfulness-based therapies are not commonly used in current practice; there is very limited access to these interventions (it is mainly offered in specialist tinnitus centres). One study that evaluated MBCT for tinnitus presented evidence that showed a clinical benefit of MBCT in improving tinnitus severity. Similar to CBT interventions, there was no clinical difference between MBCT and relaxation for tinnitus loudness, depression and anxiety.

Acceptance and commitment therapy

ACT is not routinely used in current practice in the UK for tinnitus, When ACT was compared with waiting-list control and control (web discussion forum) there was reported clinical benefit of ACT (standard-ACT and iACT) in terms of tinnitus severity, distress and depression. There was no clinical difference between ACT and comparators in terms of general quality of life, depression, anxiety and sleep.

Psychological therapies for children and young people

Psychological therapies for children and young people with tinnitus are primarily offered in specialist tinnitus centres with variability in the types of psychological therapies available. The majority of the psychological therapies used with children and young people with tinnitus have CBT principles and techniques. Narrative therapy principles and techniques are also used. The committee noted that for psychological therapies to be delivered effectively in this population, healthcare professionals need to work systemically with children and young people, involving parents, carers and teachers. No evidence was identified for the clinical effectiveness of psychological therapies in children and young people with tinnitus. The guideline committee made a recommendation for further research.

The evidence identified indicates that the psychological therapies used for the management of tinnitus have limited effects on depression and anxiety. The committee noted that the inclusion and exclusion criteria used within research may be a contributing factor to this. Whilst this guideline does not address the management of depression and anxiety in people with tinnitus as these are covered by other NICE guidelines, it was acknowledged that individuals who have mental disorders tend to be excluded from studies. As a result, participants score lower on psychological outcome measures before the initiation of psychological therapies and there is minimal improvement.

The committee also noted that there was no evidence for the use of psychological therapies for people who are d/Deaf or who have a severe-to-profound hearing loss. Standard care for tinnitus in this population is not feasible, it is important that effective interventions are developed and investigated. The committee agreed that a research recommendation is made for the use of psychological therapies for this population (see Appendix J:)

After reviewing all of the evidence and the potential benefit that psychological therapies can have in improving tinnitus outcomes, the committee felt that it would be appropriate to recommend the consideration of CBT (digital CBT, group-CBT and individual-CBT), mindfulness-based therapies and ACT for people with tinnitus. The committee agreed that a stepped approach to these psychological therapies should be considered. If a person does not benefit from the first psychological intervention they try (digital CBT) or declines an intervention, an alternative intervention from the next step should be offered (group-based tinnitus psychological therapies (CBT, ACT or mindfulness-based cognitive therapy then individual-CBT).

Use of these interventions is specifically recommended in individuals with tinnitus related distress (tinnitus that is causing an impact on emotional and social well-being and day-to-day activities). The committee decided to introduce this caveat as it was acknowledged that these interventions are generally used for severe cases of tinnitus where tinnitus cannot be managed using other interventions. Additionally, the majority of the evidence in this review evaluated psychological therapies in populations with tinnitus related distress.

1.7.2. Cost effectiveness and resource use

There was a single cost-effectiveness analysis identified in the literature conducted from a Dutch perspective.³⁷ This study considered group CBT in combination with other psychological strategies delivered using a stepped approach for people with moderate or severe tinnitus. This intervention was compared with individual consultations with a support worker when necessary. This cost-utility model found that group CBT stepped approach cost £7001 per QALY gained, which would be considered cost-effective at the £20,000 per QALY gained threshold from an NHS perspective. However, a key limitation of this Dutch study is that it is a cost-utility analysis of the entire tinnitus management pathway (see Appendix H) as opposed to the specific CBT component. Therefore, it is still unclear as to whether CBT for people with tinnitus would be a cost-effective intervention for the NHS to implement. Furthermore, there is no evidence that any psychological intervention for tinnitus is better than any other in terms of improving quality of life.

The comparative cost of different psychological therapy strategies

In order to explore the economic implications of the different psychological interventions available for people with tinnitus related distress, a costing analysis was presented to the committee. As there is no evidence of significant clinical differences between the strategies, the aim was to identify the lowest cost strategy for delivering psychological therapies. The results demonstrated that in scenarios where no second-line intervention was provided, digital CBT (which includes an online or internet based intervention with short weekly phone calls) was the least expensive intervention (£106) followed by the group interventions ranging from £174 - £201 per intervention per person. Individual CBT was the most expensive intervention at £400 per person. However, when an initial intervention proves ineffective, people with tinnitus are often provided with an additional intervention. When this was factored into the analysis (using the expert opinions of the committee) group mindfulness based therapy was the least expensive (£194 per person) and individual CBT remained the most expensive at £420 per person.

One important consideration for the committee was their level of uncertainty with respect to the proportion of people who will require an additional intervention. For example, the committee based their estimate of 5% of people requiring a second line intervention after receiving mindfulness based cognitive therapies on their experiences of current practice but this might not be generalizable to the entire NHS. The same could be said for the high (48%) estimate of people requiring an additional intervention after undergoing digital CBT. The estimate was derived from the study by Beukes (2018)⁹ where 52% of people had a TFI score less than 25, after undergoing digital CBT. This group were considered to have achieved a significant clinical improvement in their tinnitus. However, using this source may have resulted in an overestimation of the proportion that requires a second line intervention, because a change from 50 to 30 for example on the TFI may be enough such that the person does not seek or require an additional intervention. There are also likely to be some people with tinnitus who may see a small or no reduction in their score after completing the initial intervention and decide a psychological intervention is not suitable for them. Both these cases would mean that the proportion requiring an upgrade is much smaller than the estimate that has been derived from Beukes (2018).

After considering the limitations of the Beukes (2018) study, the committee agreed that 25% of people with tinnitus requiring an additional intervention after initially trying digital based CBT was a more plausible estimate, and using this assumption, the cost of digital CBT reduced to £206 per person. Mindfulness based cognitive therapy remained a slightly less expensive intervention at £194 per person (see Figure 1). However, the committee noted, based on the level of engagement a person with tinnitus has with the digital CBT approach (i.e. completing weekly sessions and ensuring weekly phone calls with clinicians take place), clinicians would be able to appropriately identify whether a group or an individual approach would be more suitable on a case by case basis. In a scenario where 12.5% of people are stepped to individual CBT and the other 12.5% is stepped to group CBT after completing digital CBT, the cost of digital CBT is further reduced to £181, becoming the least expensive intervention. Digital CBT would be less expensive than group mindfulness based cognitive therapy even if 21% of people are triaged to individual CBT and the remaining 4% receive group CBT. In practice, the committee believed that less people would require individual CBT.

Individual CBT was the most costly strategy and the committee were of the view that there is no available evidence which would suggest individual based interventions are more clinically effective for tinnitus compared with group based interventions. Therefore, individual CBT should be considered only after other interventions have been unsuccessful (i.e. digital or group based interventions).

QALY gains from psychological therapy

An important consideration for the committee was to determine whether the interventions would achieve a large enough QALY gain compared to no psychological therapy to justify the costs. Therefore, a threshold analysis was completed to demonstrate to the committee the magnitude of QALY gain that would be required for each psychological strategy to be cost-effective at the £20,000 threshold (when using estimates from Table 32). This ranged from 0.010 (group mindfulness based cognitive therapy) to 0.021 (individual CBT). The committee considered the economic evaluation considered in the guideline review by Maes (2014) which reported 0.02 QALYs gained per person when specialised care which included group CBT was compared with usual care. The committee felt that this might be an overestimate of what could be achieved in the NHS by CBT alone. In this study, usual care included audiological diagnostics and interventions such as counselling and prescription of hearing aids and sound generators. In usual care people with tinnitus were also offered one or more consultations with a social worker up to a maximum of 10 sessions. In comparison the specialised care group received tinnitus education group sessions, tympanometry, loudness level measure (this diagnostic test has not been recommended in the tinnitus guideline), individual consultations with psychologists and weekly group sessions (for 12 weeks) for people judged by the trial as having moderate or severe tinnitus. As both the intervention and the comparator are complex interventions, it is unclear if the improved health outcomes are being generated by group CBT or due to the other differences between the interventions.

Due to the limitations of the Maes (2014) study, the committee requested that they be presented with QALY gains from RCTs exploring the clinical effectiveness of psychological interventions to help people with chronic pain. This population was chosen because the committee were of the view that the way people experience symptoms of chronic pain are similar to the experiences people have with tinnitus. The QALY gains achieved in this population ranged from 0.01 to 0.02 per person. If the psychological therapy for tinnitus could achieve this level of QALY gain then it would be considered cost effective. The committee considered this to be plausible and therefore made a consensus recommendation in favour of a stepped approach to psychological therapy.

Other considerations

While group mindfulness based cognitive therapy was the least expensive intervention (when using the assumptions in Table 32), an advantage of the digital based approach over mindfulness is that people with tinnitus can receive their intervention faster and this would help to reduce the waiting list. It could also increase participation and engagement as the sessions could be completed according to an individual’s lifestyle as opposed to having to travel at a designated time. Furthermore, absences would result in increased costs per person in the group settings compared with a digital CBT based approach where the opportunity cost due to a lack of engagement is lower as the resource requirement is a short call or an email as opposed to a 1 hour session with two psychologists for group CBT. The committee acknowledged that digital CBT approaches for tinnitus are currently only available in research. However, given there is already clinical research in this area, there was a positive outlook that if digital CBT has been successfully implemented for other conditions (e.g. NICE guidelines on depression in adults, CG90) then the same could be achieved for adults with tinnitus.

In those cases where digital CBT is not an option, the committee have recommended the use of group sessions (CBT, mindfulness based cognitive therapy and ACT) as the preferred strategy. As the clinical evidence did not conclusively demonstrate that one of these group strategies was clinically preferable to another, the committee have recommended a range of therapies so that services can adopt strategies which are easiest to implement based on their existing staff and skills and thereby limiting the resource impact.

Finally, the committee discussed the importance of psychologists delivering these therapies as specialist skills are required for interventions such as CBT and ACT. If audiologists or other healthcare practitioners were to deliver these interventions, the committee stated that they would most likely be at the same grade, band 7, but would require greater supervision than a psychologist, and therefore the cost per person for each intervention would be the same or slightly higher. A research recommendation has been made to explore the clinical and cost effectiveness of interventions delivered by non-psychologists. The only exception to the specification of the member of staff was for mindfulness based-cognitive therapy where the committee explained that appropriately trained and supervised non-psychologists could deliver the intervention without requiring extra supervision.

Overall, this recommendation is expected to be cost-neutral. Currently, there is variation in practice, with some services offering psychological therapies for people with tinnitus related distress, while other regions do not have access to the required specialists in order to offer the interventions discussed in this review. There are some tinnitus clinics that do offer psychological therapy for people with tinnitus and in some cases these can be individual CBT sessions. These clinics would achieve cost-savings by opting to offer internet or group based interventions as a first line strategy instead. There is a potential for added expenditure for those services that currently do not offer psychological services, but the committee are of the view that these services should be made available. Due to a lack of conclusive cost-effectiveness evidence, the committee have made a ‘consider’ recommendation as opposed to an ‘offer’ recommendation. However, the savings that could be made by adopting internet or group based approaches in those services that are currently offering individual based interventions would at least partially offset the added expenditure incurred by those services that have not made psychological therapies available yet.

Finally the recommendations advocating the use of psychological therapies are specifically for adults, there was no clinical evidence available for children. The committee have therefore opted to make a research recommendation to identify the most clinical and cost-effective psychological therapy for children.

1.7.3. Other factors the committee took into account

The committee discussed that psychological therapies are currently mainly delivered in clinical psychology services and some audiology services. Current access to clinical psychology services can be difficult; these recommendations may require a change in service configuration. The committee also noted that few healthcare professionals are trained in delivering psychological therapies such as CBT, more training will need to be provided and available for healthcare professionals wishing to train in delivering CBT, MBCT for tinnitus and ACT.

Multidisciplinary working is essential for the successful delivery of psychological therapies, particularly to ensure that there is appropriate supervision and audiology and psychology services should be linked. Whilst digital CBT for tinnitus is not currently available in the UK, when it becomes available multidisciplinary work should still be applied.

The committee acknowledged that psychological management of tinnitus is met with scepticism by some people with tinnitus. Some people with tinnitus might refuse this option. Despite the scepticism around psychological therapies for managing tinnitus, lay representatives reported that people with tinnitus would generally welcome increased availability of individual and group psychological therapies. Digital CBT for tinnitus will be a welcome addition to the range of interventions available and may mean that individuals have quicker access to support.

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Appendices

Appendix A. Review protocols

Table 35. Review protocol: What is the clinical and cost effectiveness of psychological therapies (including cognitive behavioural therapy and mindfulness based cognitive therapy)? (PDF, 396K)

Table 36Health economic review protocol

Review question	All questions – health economic evidence
Objectives	To identify health economic studies relevant to any of the review questions.
Search criteria	Populations, interventions and comparators must be as specified in the clinical review protocol above. Studies must be of a relevant health economic study design (cost–utility analysis, cost-effectiveness analysis, cost–benefit analysis, cost–consequences analysis, comparative cost analysis). Studies must not be a letter, editorial or commentary, or a review of health economic evaluations. (Recent reviews will be ordered although not reviewed. The bibliographies will be checked for relevant studies, which will then be ordered.) Unpublished reports will not be considered unless submitted as part of a call for evidence. Studies must be in English.
Search strategy	A health economic study search will be undertaken using population-specific terms and a health economic study filter – see appendix B below.
Review strategy	Studies not meeting any of the search criteria above will be excluded. Studies published before 2003, abstract-only studies and studies from non-OECD countries or the USA will also be excluded. Each remaining study will be assessed for applicability and methodological limitations using the NICE economic evaluation checklist which can be found in appendix H of Developing NICE guidelines: the manual (2014).⁴⁸ Inclusion and exclusion criteria If a study is rated as both ‘Directly applicable’ and with ‘Minor limitations’ then it will be included in the guideline. A health economic evidence table will be completed and it will be included in the health economic evidence profile. If a study is rated as either ‘Not applicable’ or with ‘Very serious limitations’ then it will usually be excluded from the guideline. If it is excluded then a health economic evidence table will not be completed and it will not be included in the health economic evidence profile. If a study is rated as ‘Partially applicable’, with ‘Potentially serious limitations’ or both then there is discretion over whether it should be included. Where there is discretion The health economist will make a decision based on the relative applicability and quality of the available evidence for that question, in discussion with the guideline committee if required. The ultimate aim is to include health economic studies that are helpful for decision-making in the context of the guideline and the current NHS setting. If several studies are considered of sufficiently high applicability and methodological quality that they could all be included, then the health economist, in discussion with the committee if required, may decide to include only the most applicable studies and to selectively exclude the remaining studies. All studies excluded on the basis of applicability or methodological limitations will be listed with explanation in the excluded health economic studies appendix below. The health economist will be guided by the following hierarchies. Setting: UK NHS (most applicable). OECD countries with predominantly public health insurance systems (for example, France, Germany, Sweden). OECD countries with predominantly private health insurance systems (for example, Switzerland). Studies set in non-OECD countries or in the USA will be excluded before being assessed for applicability and methodological limitations. Health economic study type: Cost–utility analysis (most applicable). Other type of full economic evaluation (cost–benefit analysis, cost-effectiveness analysis, cost–consequences analysis). Comparative cost analysis. Non-comparative cost analyses including cost-of-illness studies will be excluded before being assessed for applicability and methodological limitations. Year of analysis: The more recent the study, the more applicable it will be. Studies published in 2003 or later but that depend on unit costs and resource data entirely or predominantly from before 2003 will be rated as ‘Not applicable’. Studies published before 2003 will be excluded before being assessed for applicability and methodological limitations. Quality and relevance of effectiveness data used in the health economic analysis: The more closely the clinical effectiveness data used in the health economic analysis match with the outcomes of the studies included in the clinical review the more useful the analysis will be for decision-making in the guideline.

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.⁴⁸

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 37Database date parameters and filters used

Database	Dates searched	Search filter used
Medline (OVID)	1946 – 02 April 2019	Exclusions
Embase (OVID)	1974 – 02 April 2019	Exclusions
The Cochrane Library (Wiley)	Cochrane Reviews to 2019 Issue 4 of 12 CENTRAL to 2019 Issue 4 of 12 DARE, and NHSEED to 2015 Issue 2 of 4 HTA to 2016 Issue 4 of 4	None
CINAHL, Current Nursing and Allied Health Literature (EBSCO)	Inception – 02 April 2019	Exclusions
PsycINFO (ProQuest)	Inception – 02 April 2019	Exclusions

Medline (Ovid) search terms

1.	Tinnitus/
2.	tinnit*.ti,ab.
3.	1 or 2
4.	letter/
5.	editorial/
6.	news/
7.	exp historical article/
8.	Anecdotes as Topic/
9.	comment/
10.	case report/
11.	(letter or comment*).ti.
12.	or/4-11
13.	randomized controlled trial/ or random*.ti,ab.
14.	12 not 13
15.	animals/ not humans/
16.	exp Animals, Laboratory/
17.	exp Animal Experimentation/
18.	exp Models, Animal/
19.	exp Rodentia/
20.	(rat or rats or mouse or mice).ti.
21.	or/14-20
22.	3 not 21
23.	limit 22 to English language

Embase (Ovid) search terms

1.	tinnitus/
2.	tinnit*.ti,ab.
3.	1 or 2
4.	letter.pt. or letter/
5.	note.pt.
6.	editorial.pt.
7.	Case report/ or Case study/
8.	(letter or comment*).ti.
9.	or/4-8
10.	randomized controlled trial/ or random*.ti,ab.
11.	9 not 10
12.	animal/ not human/
13.	Nonhuman/
14.	exp Animal Experiment/
15.	exp Experimental animal/
16.	Animal model/
17.	exp Rodent/
18.	(rat or rats or mouse or mice).ti.
19.	or/11-18
20.	3 not 19
21.	limit 20 to English language

Cochrane Library (Wiley) search terms

#1.	MeSH descriptor: [Tinnitus] explode all trees
#2.	tinnit*:ti,ab
#3.	#1 or #2

CINAHL (EBSCO) search terms

S1.	(MH “Tinnitus”)
S2.	(MH “Tinnitus Retraining Therapy”)
S3.	tinnit*
S4.	S1 OR S2 OR S3
S5.	PT anecdote or PT audiovisual or PT bibliography or PT biography or PT book or PT book review or PT brief item or PT cartoon or PT commentary or PT computer program or PT editorial or PT games or PT glossary or PT historical material or PT interview or PT letter or PT listservs or PT masters thesis or PT obituary or PT pamphlet or PT pamphlet chapter or PT pictorial or PT poetry or PT proceedings or PT “questions and answers” or PT response or PT software or PT teaching materials or PT website
S6.	S4 NOT S5

PsycINFO (ProQuest) search terms

1.	((MAINSUBJECT.EXACT.EXPLODE(“Tinnitus”) OR tinnit*) NOT (su.exact.explode(“rodents”) OR su.exact.explode(“mice”) OR (su.exact(“animals”) NOT (su.exact(“human males”) OR su.exact(“human females”))) OR ti(rat OR rats OR mouse OR mice))) AND la.exact(“ENG”)Limits applied

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to the tinnitus population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics and quality of life studies

Table 38Database date parameters and filters used

Database

Dates searched

Search filter used

Medline

2002 – 02 March 2019

Exclusions

Health economics studies

Quality of life studies

Embase

2002 – 02 March 2019

Exclusions

Health economics studies

Quality of life studies

Centre for Research and Dissemination (CRD)

HTA - Inception – 31 Mar 2018

NHSEED - Inception to March 2015

None

Medline (Ovid) search terms

1.	Tinnitus/
2.	tinnit*.ti,ab.
3.	1 or 2
4.	letter/
5.	editorial/
6.	news/
7.	exp historical article/
8.	Anecdotes as Topic/
9.	comment/
10.	case report/
11.	(letter or comment*).ti.
12.	or/4-11
13.	randomized controlled trial/ or random*.ti,ab.
14.	12 not 13
15.	animals/ not humans/
16.	exp Animals, Laboratory/
17.	exp Animal Experimentation/
18.	exp Models, Animal/
19.	exp Rodentia/
20.	(rat or rats or mouse or mice).ti.
21.	or/14-20
22.	3 not 21
23.	limit 22 to English language
24.	Economics/
25.	Value of life/
26.	exp “Costs and Cost Analysis”/
27.	exp Economics, Hospital/
28.	exp Economics, Medical/
29.	Economics, Nursing/
30.	Economics, Pharmaceutical/
31.	exp “Fees and Charges”/
32.	exp Budgets/
33.	budget*.ti,ab.
34.	cost*.ti.
35.	(economic* or pharmaco?economic*).ti.
36.	(price* or pricing*).ti,ab.
37.	(cost* adj2 (effective* or utilit* or benefit* or minimi* or unit* or estimat* or variable*)).ab.
38.	(financ* or fee or fees).ti,ab.
39.	(value adj2 (money or monetary)).ti,ab.
40.	or/24-39
41.	quality-adjusted life years/
42.	sickness impact profile/
43.	(quality adj2 (wellbeing or well being)).ti,ab.
44.	sickness impact profile.ti,ab.
45.	disability adjusted life.ti,ab.
46.	(qal* or qtime* or qwb* or daly*).ti,ab.
47.	(euroqol* or eq5d* or eq 5*).ti,ab.
48.	(qol* or hql* or hqol* or h qol* or hrqol* or hr qol*).ti,ab.
49.	(health utility* or utility score* or disutilit* or utility value*).ti,ab.
50.	(hui or hui1 or hui2 or hui3).ti,ab.
51.	(health* year* equivalent* or hye or hyes).ti,ab.
52.	discrete choice*.ti,ab.
53.	rosser.ti,ab.
54.	(willingness to pay or time tradeoff or time trade off or tto or standard gamble*).ti,ab.
55.	(sf36* or sf 36* or short form 36* or shortform 36* or shortform36*).ti,ab.
56.	(sf20 or sf 20 or short form 20 or shortform 20 or shortform20).ti,ab.
57.	(sf12* or sf 12* or short form 12* or shortform 12* or shortform12*).ti,ab.
58.	(sf8* or sf 8* or short form 8* or shortform 8* or shortform8*).ti,ab.
59.	(sf6* or sf 6* or short form 6* or shortform 6* or shortform6*).ti,ab.
60.	or/41-59
61.	23 and (40 or 60)

Embase (Ovid) search terms

1.	tinnitus/
2.	tinnit*.ti,ab.
3.	1 or 2
4.	letter.pt. or letter/
5.	note.pt.
6.	editorial.pt.
7.	Case report/ or Case study/
8.	(letter or comment*).ti.
9.	or/4-8
10.	randomized controlled trial/ or random*.ti,ab.
11.	9 not 10
12.	animal/ not human/
13.	Nonhuman/
14.	exp Animal Experiment/
15.	exp Experimental animal/
16.	Animal model/
17.	exp Rodent/
18.	(rat or rats or mouse or mice).ti.
19.	or/11-18
20.	3 not 19
21.	health economics/
22.	exp economic evaluation/
23.	exp health care cost/
24.	exp fee/
25.	budget/
26.	funding/
27.	budget*.ti,ab.
28.	cost*.ti.
29.	(economic* or pharmaco?economic*).ti.
30.	(price* or pricing*).ti,ab.
31.	(cost* adj2 (effective* or utilit* or benefit* or minimi* or unit* or estimat* or variable*)).ab.
32.	(financ* or fee or fees).ti,ab.
33.	(value adj2 (money or monetary)).ti,ab.
34.	or/21-33
35.	quality adjusted life year/
36.	"quality of life index"/
37.	short form 12/ or short form 20/ or short form 36/ or short form 8/
38.	sickness impact profile/
39.	(quality adj2 (wellbeing or well being)).ti,ab.
40.	sickness impact profile.ti,ab.
41.	disability adjusted life.ti,ab.
42.	(qal* or qtime* or qwb* or daly*).ti,ab.
43.	(euroqol* or eq5d* or eq 5*).ti,ab.
44.	(qol* or hql* or hqol* or h qol* or hrqol* or hr qol*).ti,ab.
45.	(health utility* or utility score* or disutilit* or utility value*).ti,ab.
46.	(hui or hui1 or hui2 or hui3).ti,ab.
47.	(health* year* equivalent* or hye or hyes).ti,ab.
48.	discrete choice*.ti,ab.
49.	rosser.ti,ab.
50.	(willingness to pay or time tradeoff or time trade off or tto or standard gamble*).ti,ab.
51.	(sf36* or sf 36* or short form 36* or shortform 36* or shortform36*).ti,ab.
52.	(sf20 or sf 20 or short form 20 or shortform 20 or shortform20).ti,ab.
53.	(sf12* or sf 12* or short form 12* or shortform 12* or shortform12*).ti,ab.
54.	(sf8* or sf 8* or short form 8* or shortform 8* or shortform8*).ti,ab.
55.	(sf6* or sf 6* or short form 6* or shortform 6* or shortform6*).ti,ab.
56.	or/35-55
57.	20 and (34 or 56)
58.	limit 57 to English language

NHS EED and HTA (CRD) search terms

#1.	MeSH DESCRIPTOR Tinnitus EXPLODE ALL TREES
#2.	(tinnit*)
#3.	#1 OR #2

Appendix C. Clinical evidence selection

Figure 2Flow chart of clinical study selection for the review of psychological therapies

Appendix D. Clinical evidence tables

Download PDF (819K)

Appendix E. Forest plots

Cognitive behavioural therapy

E.1. CBT versus waiting-list control

Figure 3Tinnitus severity (post-treatment); GSI, scale not reported

Figure 4Tinnitus distress (post-treatment); TQ/TRQ

Scales: Henry 1996 (TRQ) – 0-104; Kroner-Herwig 2003 (TQ) – 0-84

Figure 5Tinnitus distress (3 months); TRQ, scale 0-104

Figure 6Tinnitus QoL (post-treatment); THQ, scale not reported

Figure 7Tinnitus annoyance (post-treatment); VAS

Scales: Henry 1996 – 0-4; Kroner-Herwig 1995 – 0-10

Figure 8Tinnitus loudness (post-treatment); VAS

Scales: Henry 1996 – 0-4 (unclear); Kroner-Herwig 1995 – 0-10; Kroner-Herwig 2003 – 1-7

Figure 9Depression (post-treatment);BDI/ADS

Scales: Henry 1996 (BDI) – 0-63; Kroner-Herwig 2003 (ADS) – 0-60

Figure 10Depression (3 months); HADS, scale 0-21

Figure 11Anxiety (3 months); ASI, scale not reported

Figure 12Anxiety (HADS) (3 months); HADS, scale 0-21

Figure 13Sleep disturbance (post-treatment); VAS, scale 0-10

E.2. CBT versus control (masking)

Figure 14Tinnitus severity (post-treatment); THI, scale 0-100

Figure 15Depression (post-treatment); SCL-90 depression, subscale 1-5

Figure 16Anxiety (post-treatment); SCL-90 anxiety, subscale 1-5

E.3. CBT versus information only

Figure 17Tinnitus distress (post-treatment); TQ, scale 0-84

Scale

Figure 18Tinnitus distress (9 months); TQ, scale 0-84

Figure 19Depression (post-treatment); PHQ-D, scale not reported

Figure 20Depression (9 months); PHQ-D, scale not reported

E.4. CBT versus education

Figure 21Tinnitus severity (Global Severity Index) (post-treatment)

Figure 22Tinnitus distress (post-treatment); TRQ/TQ

Scales: Henry 1996 (TRQ) – 0-104; Kroner-Herwig 2003 and Zachriat 2004 (TQ) – 0-84

Figure 23Tinnitus distress (12 months); TRQ, scale 0-104

Figure 24Tinnitus QoL (post-treatment); THQ, scale unclear

Figure 25Tinnitus QoL (12 months); THQ, scale unclear

Figure 26Tinnitus loudness (post-treatment)

Scales: Henry 1996 (VAS) – 0-4; Zachriat 2004 (subjective change) – 1-7

Figure 27Tinnitus loudness (diary) (post-treatment)

Figure 28Tinnitus annoyance (post-treatment); VAS, scale 0-4 (unclear)

Figure 29Tinnitus annoyance (12 months); VAS, scale 0-4 (unclear)

Figure 30Depression (post-treatment); BDI, scale 0-63

Figure 31Depression (12 months); BDI/ADS

Scales: Henry 1996 (BDI) – 0-63; Kroner-Herwig 2003 (ADS) – 0-60

E.5. CBT versus relaxation

Figure 32Tinnitus severity (post-treatment); Global Severity Index, scale not reported

Figure 33Tinnitus distress (post-treatment); TQ, scale 0-84

Figure 34Tinnitus loudness (post-treatment); diary, scale 1-7

Figure 35Depression (post-treatment); ADS, scale 0-60

E.6. CBT versus passive relaxation training

Figure 36Tinnitus distress (post-treatment); TEQ, scale not reported

Figure 37Tinnitus distress (4 months); TEQ, scale not reported

Figure 38Tinnitus loudness (post-treatment); tinnitus loudness rating, scale 1-5

Figure 39Tinnitus loudness (4 months); tinnitus loudness rating, scale 1-5

Figure 40Tinnitus annoyance (post-treatment); annoyance rating, scale not reported

Figure 41Tinnitus annoyance (4 months); annoyance rating, scale not reported

Figure 42Depression (1 month); BDI, 0-63

Figure 43Anxiety (1 month); STAI-state, scale 20-80

Figure 44Anxiety (1 month); STAI-trait, scale 20-80

Figure 45Insomnia (post-treatment); TEQ, scale not reported

Figure 46Insomnia (4 months); TEQ, scale not reported

E.7. CBT versus applied relaxation training

Figure 47Tinnitus distress (post-treatment);TEQ, scale not reported

Figure 48Tinnitus distress (4 months);TEQ, scale not reported

Figure 49Tinnitus loudness (post-treatment); tinnitus loudness rating, scale 1-5

Figure 50Tinnitus loudness (4 months); tinnitus loudness rating, scale 1-5

Figure 51Tinnitus annoyance (post-treatment); annoyance rating, scale not reported

Figure 52Tinnitus annoyance (4 months); annoyance rating, scale not reported

Figure 53Depression (1 month); BDI, 0-63

Figure 54Anxiety (1 month); STAI-state, scale 20-80

Figure 55Anxiety (1 month); STAI-trait, scale 20-80

Figure 56Insomnia (post-treatment);TEQ, scale not reported

Figure 57Insomnia (4 months);TEQ, scale not reported

Source: <Insert Source text here>

E.8. CBT-stepped intervention versus usual care

Figure 58Tinnitus severity (post-treatment) (step 1); TQ, scale 0-84

Figure 59Tinnitus severity (12 months) (step 2); TQ, scale 0-84

Figure 60Quality of life (post-treatment) (step 1); HUI, scale -0.36-1

Figure 61Quality of life (12 months) (step 2); HUI, scale -0.36-1

Figure 62Tinnitus-related quality of life (post-treatment) (step 1); THI, scale 0-100

Figure 63Tinnitus-related quality of life (12 months) (step 2); THI, scale 0-100

Figure 64Depression and anxiety (post-treatment) (step 1); HADS, scale 0-42

Figure 65Depression and anxiety (12 months) (step 2); HADS, scale 0-42

E.9. CBT (self-help book) versus waiting-list control

Figure 66Tinnitus distress (3 months); TRQ, scale 0-104

E.10. CBT (bibliotherapy/self-help) versus information only

Figure 67Tinnitus distress (post-treatment); TQ, scale 0-84

Figure 68Tinnitus distress (9 months); TQ, scale 0-84

Figure 69Depression (post-treatment); PHQ-D, scale not reported

Figure 70Depression (9 months); PHQ-D, scale not reported

E.11. CBT versus control (web discussion forum)

Figure 71Tinnitus distress (post-treatment); Mini-TQ, scale 0-24

Figure 72Tinnitus severity (post-treatment); THI, scale 0-100

Figure 73Depression (post-treatment); HADS, scale 0-21

Figure 74Anxiety (post-treatment); HADS, scale 0-21

Figure 75Sleep (post-treatment); ISI, scale 0-28

E.12. iCBT versus waiting-list control

Figure 76Tinnitus annoyance (post-treatment); VAS, scale 0-10

Figure 77Tinnitus loudness (post-treatment); VAS, scale 0-10

Figure 78Depression (post-treatment); HADS, scale 0-21

Figure 79Depression (1 year); HADS, scale 0-21

Figure 80Anxiety (post-treatment); HADS, scale 0-21

Figure 81Anxiety (1 year); HADS, scale 0-21

Figure 82Sleep (post-treatment), VAS, scale 0-10

E.13. iCBT versus information only

Figure 83Tinnitus distress (post-treatment); TQ/TRQ, scale 0-84

Scales: Abbott 2009 (TRQ) – 0-104; Nyenhuis 2013 (TQ) – 0-84

Figure 84Tinnitus distress (9 months); TQ, scale 0-84

Figure 85Tinnitus annoyance (post-treatment); VAS, scale 0-10

Figure 86Tinnitus loudness (post-treatment); VAS, scale 0-10

Figure 87Depression (post-treatment); PHQ-D/DASS

Scales: Abbott 2009 (DASS) – 0-120; Nyenhuis 2013 (PHQ-D), scale not reported

Figure 88Depression (9 months); PHQ-D, scale not reported

Figure 89Anxiety (post-treatment); DASS, scale 0-120

Figure 90Sleep (post-treatment); VAS, scale 0-10

E.14. iCBT versus tinnitus information counselling

Figure 91Tinnitus severity (post-treatment); THI, scale 0-100

Figure 92Tinnitus severity (2 months); THI, scale 0-100

Figure 93Tinnitus distress (post-treatment); TFI, scale 0-100

Figure 94Tinnitus distress (2 months); TFI, scale 0-100

Figure 95Quality of life (post-treatment); SWLS (Satisfaction With Life Scales, scale 5-35

Figure 96Quality of life (2 months); SWLS (Satisfaction With Life Scales, scale 5-35

Figure 97Depression (post-treatment); PHQ-9, scale 0-27

Figure 98Depression (2 months); PHQ-9, scale 0-27

Figure 99Anxiety (post-treatment); GAD-7, scale 0-21

Figure 100Anxiety (2 months); GAD-7, scale 0-21

Figure 101Sleep (post-treatment); ISI, scale 0-28

Figure 102Sleep (2 months); ISI, scale 0-28

E.15. iCBT versus control (web discussion forum)

Figure 103Tinnitus severity and distress (8-10 weeks); THI, scale 0-100

Figure 104Tinnitus distress (8-10 weeks); Mini-TQ, scale 0-20

Figure 105Quality of life (8 weeks); QoLI, scale not reported

Figure 106Depression (8-10 weeks); HADS, scale 0-21

Figure 107Anxiety (8-10 weeks); HADS, scale 0-21

Figure 108Sleep (8-10 weeks), ISI, scale 0-28

E.16. iCBT versus iACT

Figure 109Tinnitus distress and severity (8 weeks);THI, scale 0-100

Figure 110Tinnitus distress and severity (12 months); THI, scale 0-100

Figure 111Quality of life (8 weeks); QoLI, scale not reported

Figure 112Quality of life (12 months) QoLI, scale not reported

Figure 113Anxiety (8 weeks); HADS, scale 0-21

Figure 114Anxiety (12 months); HADS, scale 0-21

Figure 115Depression (8 weeks); HADS, scale 0-21

Figure 116Depression (12 months); HADS, scale 0-21

Figure 117Sleep (8 weeks); ISI, scale 0-28

Figure 118Sleep (12 months); ISI, scale 0-28

E.17. Biofeedback versus waiting-list control

Figure 119Tinnitus distress (8 weeks); Tinnitus diary, scale not reported

Figure 120Tinnitus distress (6 months); TQ, scale 0-84

Figure 121Quality of life (8 weeks); Health Life Satisfaction, scale not reported

Figure 122Quality of life (6 months); Health Life Satisfaction, scale not reported

Figure 123Tinnitus loudness (8 weeks); Tinnitus diary, scale 0-10

Figure 124Tinnitus loudness (6 months); Tinnitus diary, scale 0-10

E.18. Biofeedback-based CBT versus waiting-list control

Figure 125Tinnitus severity (3 months); Global Severity Index of SLC-90-R, scale not reported

Figure 126Tinnitus distress (3 months); TQ, scale 0-84

Figure 127Tinnitus distress (3 months); Tinnitus diary, scale not reported

Figure 128Tinnitus loudness (3 months); Tinnitus diary, scale 0-10

Figure 129Depression (3 months); BDI, scale 0-63

Figure 130Sleep (3 months); Sleep disturbance diary, scale 0-10

E.19. Behavioural therapy versus waiting-list control

Figure 131Tinnitus loudness (direct) (post-treatment); Diary, scale 0-10

Figure 132Tinnitus loudness (retrospective) (post-treatment); Diary, scale 0-10

Figure 133Tinnitus annoyance (retrospective) (post-treatment); Diary, scale 0-10 (unclear)

Figure 134Depression (retrospective) (post-treatment); Diary, scale 0-10

Mindfulness-based therapies

E.20. Mindfulness-based cognitive therapy versus relaxation

Figure 135Tinnitus severity (post-treatment); TQ, scale 0-84

Figure 136Tinnitus severity (6 months); TQ, scale 0-84

Figure 137Tinnitus severity (post-treatment); TFI, scale 0-100

Figure 138Tinnitus severity (6 months); TFI, scale 0-100

Figure 139Tinnitus loudness (post-treatment); VAS, scale 0-100

Figure 140Tinnitus loudness (6 months); VAS, scale 0-100

Figure 141Depression (post-treatment); HADS/BDI

Scales: McKenna 2017 (HADS) – 0-21; Philpott 2012 (BDI) – 0-63

Figure 142Depression (6 months); HADS/BDI

Scales: McKenna 2017 (HADS) – 0-21; Philpott 2012 (BDI) – 0-63

Figure 143Anxiety (post-treatment); HADS/STRAI

Scales: McKenna 2017 (HADS) – 0-21; Philpott 2012 (STRAI) – 20-80

Figure 144Anxiety (3-6 months); HADS/STRAI

Scales: McKenna 2017 (HADS) – 0-21; Philpott 2012 (STRAI) – 20-80

E.21. Mindfulness meditation versus relaxation therapy

Figure 145Tinnitus severity (post-treatment), VAS, scale 0-10

Figure 146Tinnitus loudness (post-treatment), VAS, scale 0-10

Figure 147Anxiety (post-treatment), HADS, scale 0-21

Figure 148Depression (post-treatment); HADS, scale 0-21

Figure 149Depression and anxiety (post-treatment), HADS (total), scale 0-42

E.22. Mindfulness and body-psychotherapy-based group treatment versus waiting-list control

Figure 150Tinnitus severity (post-treatment); TQ, scale 0-84

Figure 151Tinnitus severity (post-treatment); THI, scale 0-100

Figure 152Tinnitus annoyance (post-treatment); VAS, scale not reported

Figure 153Tinnitus loudness (post-treatment); VAS, scale not reported

Figure 154Depression (post-treatment); BDI, scale 0-62

Acceptance and commitment therapy

E.23. iACT versus control (web discussion forum)

Figure 155Tinnitus severity and distress (post-treatment); THI, scale 0-100

Figure 156Quality of life (post-treatment); QoLI, scale not reported

Figure 157Depression (post-treatment); HADS, scale 0-21

Figure 158Anxiety (post-treatment); HADS, scale 0-21

Figure 159Sleep (post-treatment); ISI, scale 0-28

E.24. ACT versus waiting-list control

Figure 160Tinnitus severity (post-treatment); THI, scale 0-100

Figure 161Quality of life (post-treatment); QoLI, scale not reported

Figure 162Depression (post-treatment); HADS, scale 0-21

Figure 163Anxiety (post-treatment); HADS, scale 0-21

Figure 164Sleep (post-treatment-10 weeks); ISI, 0-28

Appendix F. GRADE tables

Table 39Clinical evidence profile: CBT versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: Global Severity Index (GSI of SCL-90R); Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	43	20	-	MD 0.09 lower (0.31 lower to 0.13 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up post-treatment; measured with: TQ/TRQ; range of scores: 0-84, 0-104; Better indicated by lower values)
2	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	63	40	-	SMD 0.74 lower (1.16 to 0.33 lower)	⨁⨁◯◯ LOW	CRITICAL
Tinnitus distress (follow-up 3 months; measured with: TRQ; range of scores: 0-104; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	11	-	MD 22.80 lower (34.50 to 11.10 lower)	⨁⨁◯◯ LOW	CRITICAL
Tinnitus QoL (follow-up post-treatment; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	20	20	-	MD 17.16 lower (27.88 to 6.44 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus annoyance (follow-up post-treatment; measured with: VAS; range of scores: 0-4, 0-10; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	36	-	SMD 0.35 lower (0.84 lower to 0.14 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up post-treatment; measured with: VAS; range of scores: 0-4, 0-10; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	73	56	-	SMD 0.27 lower (0.64 lower to 0.09 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up post-treatment; measured with: BDI/ADS; range of scores: 0-63, 0-60; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	63	40	-	SMD 0.21 lower (0.62 lower to 0.2 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 3 months; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	11	-	MD 3.20 lower (6.58 lower to 0.18 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 3 months; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	11	-	MD 4 lower (6.21 to 1.79 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 3 months; measured with: ASI; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	12	11	-	MD 14.7 lower (21.54 to 7.86 lower)	⨁⨁◯◯ LOW	IMPORTANT
Sleep disturbance (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	16	-	MD 0.34 lower (1.98 lower to 1.3 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 40Clinical evidence profile: CBT versus control (masking)

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Control (masking)	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: Tinnitus Handicap Inventory; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	50	50	-	MD 12.94 lower (16.32 to 9.56 lower)	⨁⨁◯◯ LOW	CRITICAL
Depression (follow-up post-treatment; measured with: Symptom Checklist-90; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	50	50	-	MD 0.3 lower (0.56 to 0.04 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: Symptom Checklist-90; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	50	50	-	MD 0.78 lower (0.99 to 0.57 lower)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 41Clinical evidence profile: CBT versus information only

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Information only	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up post-treatment; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	47	58	-	MD 7.40 lower (13.65 to 1.15 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 9 months; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	47	49	-	MD 6.8 lower (13.09 to 0.51 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: PHQ-D; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	47	58	-	MD 1.00 lower (2.85 lower to 0.85 higher)	⨁⨁◯◯ LOW	IMPORTANT
Depression (follow-up 9 months; measured with: PHQ-D; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	47	49	-	MD 0.9 lower (2.69 lower to 0.89 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 42Clinical evidence profile: CBT versus education

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Education	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: Global Severity Index (GSI of SCL-90R); Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	43	16	-	MD 0.01 higher (0.23 lower to 0.25 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up post-treatment; measured with: TQ/TRQ; range of scores: 0-84, 0-104; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	90	56	-	SMD 0.40 lower (0.75 lower to 0.06 higher)	⨁⨁◯◯ LOW	CRITICAL
Tinnitus distress (follow-up 12 months; measured with: TRQ; range of scores: 0-104; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	16	17	-	MD 1.88 lower (16.69 lower to 12.93 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus QoL (follow-up post-treatment; measured with: THQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	20	20	-	MD 15.62 lower (26.51 to 4.73 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus QoL (follow-up 12 months; measured with: THQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	16	17	-	MD 2.76 lower (14.69 lower to 9.17 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up post-treatment; measured with: VAS and subjective change; range of scores: 0-4; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	47	40	-	SMD 0.32 lower (0.74 lower to 0.11 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up 11 weeks - 6 months; measured with: Diary; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	70	36	-	MD 0.06 lower (0.78 lower to 0.67 higher)	⨁⨁◯◯ LOW	IMPORTANT
Tinnitus annoyance (follow-up post-treatment; measured with: VAS; range of scores: 0-4; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	20	20	-	MD 0.46 lower (0.95 lower to 0.03 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (follow-up 12 months; measured with: VAS; range of scores: 0-4; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	16	17	-	MD 0.63 lower (1.37 lower to 0.11 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up post-treatment; measured with: BDI; range of scores: 0-63; Better indicated by lower values)
1	randomised trials	very serious²	no serious inconsistency	no serious indirectness	very serious²	none	20	20	-	MD 0.45 higher (4.39 lower to 5.29 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 6-12 months; measured with: BDI/ADS; range of scores: 0-63, 0-60; Better indicated by lower values)
2	randomised trials	very serious²	no serious inconsistency	no serious indirectness	serious²	none	59	33	-	SMD 0.06 lower (0.5 lower to 0.38 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 43Clinical evidence profile: CBT versus relaxation

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Relaxation	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: Global Severity Index (GSI of SCL-90R; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	43	16	-	MD 0.21 lower (0.55 lower to 0.13 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up post-treatment; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	43	16	-	MD 7.6 lower (13.95 to 1.25 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up post-treatment; measured with: Diary; range of scores: 1-7; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	43	16	-	MD 0.04 lower (0.93 lower to 0.85 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up post-treatment; measured with: ADS; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	43	16	-	MD 5.93 lower (12.11 lower to 0.25 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 44Clinical evidence profile: CBT versus passive relaxation training

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Passive relaxation training	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up post-treatment; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	11	10	-	MD 0.3 higher (2.2 lower to 2.8 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 4 months; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	6	-	MD 0.2 lower (2.33 lower to 1.93 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up post-treatment; measured with: Tinnitus loudness rating; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	11	7	-	MD 0 higher (0.72 lower to 0.72 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up 4 months; measured with: Tinnitus loudness rating; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	10	6	-	MD 0.03 lower (0.54 lower to 0.48 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (most annoying) (follow-up post-treatment; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	11	7	-	MD 0.75 higher (0.1 to 1.4 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (most annoying) (follow-up 4 months; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	6	-	MD 0 higher (0.71 lower to 0.71 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 1 month; measured with: BDI; range of scores: 0-63; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	6	-	MD 3.36 lower (13.24 lower to 6.52 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 1 month; measured with: STAI- state; range of scores: 20-80; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	6	-	MD 6.46 lower (21.31 lower to 8.39 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 1 month; measured with: STAI-trait; range of scores: 20-80; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	10	6	-	MD 7.06 lower (18.48 lower to 4.36 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Insomnia (follow-up post-treatment; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	11	7	-	MD 0.03 higher (2.09 lower to 2.15 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Insomnia (follow-up 4 months; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	6	-	MD 0.13 lower (2.05 lower to 1.79 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 45Clinical evidence profile: CBT versus applied relaxation training

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Applied relaxation training	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up post-treatment; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	11	12	-	MD 0.7 lower (2.64 lower to 1.24 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 4 months; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	10	11	-	MD 0.85 higher (1.07 lower to 2.77 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up post-treatment; measured with: Tinnitus loudness rating; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	11	12	-	MD 0.34 higher (0.35 lower to 1.03 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up 4 months; measured with: Tinnitus loudness rating; range of scores: 1-5; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	10	11	-	MD 0.3 higher (0.24 lower to 0.84 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (most annoying) (follow-up post-treatment; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	11	12	-	MD 0.52 higher (0.13 lower to 1.17 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (most annoying) (follow-up 4 months; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	10	11	-	MD 0.82 higher (0 to 1.64 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 1month; measured with: BDI; range of scores: 0-63; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	12	-	MD 0.97 higher (4.09 lower to 6.03 higher)	⨁◯◯◯ VERY LOW
Anxiety (follow-up 1 month; measured with: STAI-state; range of scores: 20-80; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	12	-	MD 1.21 lower (12.12 lower to 9.7 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 1 month; measured with: STAI-trait; range of scores: 20-80; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	12	-	MD 0.77 higher (6.78 lower to 8.32 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Insomnia (follow-up post-treatment; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	11	12	-	MD 0.02 higher (1.75 lower to 1.79 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Insomnia (follow-up 4 months; measured with: TEQ; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	10	11	-	MD 0.11 higher (0.93 lower to 1.15 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 46Clinical evidence profile: CBT-stepped intervention versus usual care

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT-stepped intervention	Usual care	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment (step 1); measured with: Tinnitus Questionnaire; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	no serious imprecision	none	200	194	-	MD 3.5 lower (7.4 lower to 0.4 higher)	⨁⨁⨁⨁ HIGH	CRITICAL
Tinnitus severity (follow-up 12 months (step 2); measured with: Tinnitus Questionnaire; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	171	161	-	MD 8.69 lower (12.66 to 4.72 lower)	⨁⨁⨁◯ MODERATE	CRITICAL
Quality of life (follow-up post-treatment (step 1); measured with: Health Utilities Index; range of scores: -0.36-1; Better indicated by higher values)
1	randomised trials	serious²	no serious inconsistency	no serious indirectness	no serious imprecision	none	200	194	-	MD 0.02 lower (0.08 lower to 0.04 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Quality of life (follow-up 12 months (step 2); measured with: Health Utilities Index; range of scores: -0.36-1; Better indicated by lower values)
1	randomised trials	serious²	no serious inconsistency	no serious indirectness	no serious imprecision	none	171	171	-	MD 0.05 higher (0.01 to 0.11 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus-related quality of life (follow-up post-treatment (step 1); measured with: Tinnitus Handicap Inventory; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	no serious imprecision	none	200	194	-	MD 3.13 lower (7.79 lower to 1.53 higher)	⨁⨁⨁⨁ HIGH	CRITICAL
Tinnitus-related quality of life (follow-up 12 months (step 2); measured with: Tinnitus Handicap Inventory; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	171	161	-	MD 7.06 lower (11.63 to 2.49 lower)	⨁⨁⨁◯ MODERATE	CRITICAL
Depression and anxiety (follow-up post-treatment (step 1); measured with: Hospital Anxiety and Depression Inventory; range of scores: 0-42; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	no serious imprecision	none	200	194	-	MD 0.17 lower (1.82 lower to 1.48 higher)	⨁⨁⨁⨁ HIGH	IMPORTANT
Depression and anxiety (follow-up 12 months (step 2); measured with: Hospital Anxiety and Depression Inventory; range of scores: 0-42; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	no serious imprecision	none	171	161	-	MD 0.61 lower (2.24 lower to 1.02 higher)	⨁⨁⨁⨁ HIGH	IMPORTANT

1: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.
2: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias

Table 47Clinical evidence profile: CBT (self-help book) versus waiting-list control

Quality assessment

No of patients

Effect

Quality

Importance

No of studies

Design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerations

CBT (book)

Waiting-list control

Relative (95% CI)

Absolute

Tinnitus distress (follow-up 3 months; measured with: TRQ; range of scores: 0-104; Better indicated by lower values)

randomised trials

very serious¹

no serious inconsistency

no serious indirectness

serious²

none

MD 5.12 lower (10.66 lower to 0.42 higher)

⨁◯◯◯

VERY LOW

CRITICAL

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 48Clinical evidence profile: CBT (bibliotherapy) versus information only

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT bibliotherapy	Information only	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up post-treatment; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	51	58	-	MD 1.10 lower (8.37 lower to 6.17 higher)	⨁⨁◯◯ LOW	CRITICAL
Tinnitus distress (follow-up 9 months; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	45	49	-	MD 4.40 lower (11.64 lower to 2.84 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: PHQ-D; range of scores: 0-120; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	51	58	-	MD 0.70 higher (1.34 lower to 2.74 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 9 months; measured with: PHQ-D; range of scores: 0-120; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	45	49	-	MD 0.80 higher (1.29 lower to 2.89 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 49Clinical evidence profile: CBT versus control (web discussion forum)

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CBT	Control (web discussion forum)	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up mean 10 weeks; measured with: Mini-TQ; range of scores: 0-24; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	38	43	-	MD 3 lower (5.33 to 0.67 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus severity (follow-up mean 10 weeks; measured with: THI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	38	43	-	MD 9.76 lower (18.74 to 0.78 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up mean 10 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious¹	none	38	43	-	MD 1.47 lower (3.28 lower to 0.34 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up mean 10 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	38	43	-	MD 1.83 lower (3.68 lower to 0.02 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep (ISI) (follow-up mean 10 weeks; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	38	43	-	MD 1.88 lower (4.92 lower to 1.16 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 50Clinical evidence profile: iCBT versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iCBT	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus annoyance (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious	none	25	59	-	MD 0.5 lower (1.56 lower to 0.56 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	24	59	-	MD 0.2 lower (1.26 lower to 0.86 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up post-treatment; measured with: HADS - depression; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	24	48	-	MD 0.8 lower (2.76 lower to 1.16 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 1 year; measured with: HADS - depression; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	46	50	-	MD 0 higher (1.56 lower to 1.56 higher)	⨁⨁◯◯ LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: HADS - anxiety; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	24	48	-	MD 0.9 lower (2.88 lower to 1.08 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 1 year; measured with: HADS - anxiety; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	46	50	-	MD 0.3 lower (2.02 lower to 1.42 higher)	⨁⨁◯◯ LOW	IMPORTANT
Sleep (follow-up post-treatment; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	24	58	-	MD 0.60 lower (0.47 lower to 1.67 higher)	⨁⨁◯◯ LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 51Clinical evidence profile: iCBT versus information only

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iCBT	Information only	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up post-treatment; measured with: TQ/TRQ; range of scores: 0-84, 0-104; Better indicated by lower values)
1	randomised trials	very serious¹	serious²	no serious indirectness	serious³	none	80	81	-	SMD 0.34 lower (0.66 to 0.03 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 9 months; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious³	none	44	49	-	MD 5.8 lower (12.71 lower to 1.11 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus annoyance (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious³	none	28	23	-	MD 0.23 lower (1.1 lower to 0.64 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious³	none	28	23	-	MD 0.1 higher (0.84 lower to 1.04 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: DASS/PHQ-D; range of scores: - 0-120, not reported; Better indicated by lower values)
2	randomised trials	very serious¹	serious²	no serious indirectness	serious³	none	80	81	-	SMD 0.05 higher (0.26 lower to 0.36 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 9 months; measured with: PHQ-D; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	44	49	-	MD 0.2 higher (1.92 lower to 2.32 higher)	⨁⨁◯◯ LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: DASS; range of scores: 0-120; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious³	none	28	23	-	MD 0.7 higher (1.46 lower to 2.86 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep quality (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious³	none	28	23	-	MD 0.1 lower (1.24 lower to 1.04 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 or 2 increments because heterogeneity, I2= > 50%, p= > 0.04, unexplained by subgroup analysis.
3: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 52Clinical evidence profile: iCBT versus tinnitus information counselling

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iCBT	Tinnitus information counselling	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: Tinnitus Handicap Inventory; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	44	44	-	MD 6.41 lower (14.71 lower to 1.89 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus severity (follow-up 2 months; measured with: Tinnitus Handicap Inventory; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	37	37	-	MD 9.33 lower (17.77 to 0.89 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up post-treatment; measured with: Tinnitus Functional Index; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	44	44	-	MD 7 lower (16.6 lower to 2.6 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 2 months; measured with: Tinnitus Functional Index; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	37	37	-	MD 9.66 lower (19.4 lower to 0.08 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life (follow-up post-treatment; measured with: Satisfaction With Life Scales; range of scores: 5-35; Better indicated by higher values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	44	44	-	MD 0.05 higher (2.16 lower to 2.26 higher)	⨁⨁◯◯ LOW	CRITICAL
Quality of life (follow-up 2 months; measured with: Satisfaction With Life Scales; range of scores: 5-35; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	37	37	-	MD 0.5 higher (1.78 lower to 2.78 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: Patient Health Questionnaire-9; range of scores: 0-27; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	44	44	-	MD 0.52 lower (2.14 lower to 1.1 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 2 months; measured with: Patient Health Questionnaire-9; range of scores: 0-27; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	37	37	-	MD 2.19 lower (3.95 to 0.43 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: Generalised Anxiety Disorder-7; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	44	44	-	MD 0.12 higher (1.43 lower to 1.67 higher)	⨁⨁◯◯ LOW	IMPORTANT
Anxiety (follow-up 2 months; measured with: Generalised Anxiety Disorder-7; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	37	37	-	MD 0.09 lower (1.64 lower to 1.46 higher)	⨁⨁◯◯ LOW	IMPORTANT
Sleep (follow-up post-treatment; measured with: Insomnia Severity Index; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	44	44	-	MD 2.84 lower (5.42 to 0.26 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep (follow-up 2 months; measured with: Insomnia Severity Index; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	37	37	-	MD 4.34 lower (7.01 to 1.67 lower)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 53Clinical evidence profile: iCBT versus control (web discussion forum)

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iCBT	Control (web discussion forum)	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity and distress (follow-up 8-10 weeks; measured with: THI; range of scores: 0-100; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	126	136	-	MD 12.16 lower (16.37 to 7.96 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 8-10 weeks; measured with: Mini-TQ; range of scores: 0-20; Better indicated by lower values)
2	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	96	104	-	MD 4.42 lower (5.74 to 3.1 lower)	⨁⨁◯◯ LOW	CRITICAL
Quality of life (follow-up 8 weeks; measured with: QoLI; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	32	-	MD 0.26 higher (0.5 lower to 1.02 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up 8-10 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	126	136	-	MD 1.95 lower (2.89 to 1.02 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 8-10 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	126	136	-	MD 1.66 lower (2.53 to 0.79 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep (follow-up 8-10 weeks; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
3	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	126	136	-	MD 2.9 lower (4.42 to 1.38 lower)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 54Clinical evidence profile: iCBT versus iACT

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iCBT	iACT	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress and severity (follow-up 8 weeks; measured with: THI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	33	-	MD 6.99 higher (1.64 lower to 15.62 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress and severity (follow-up 12 months; measured with: THI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	31	-	MD 3.79 lower (14.76 lower to 7.18 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life (follow-up 8 weeks; measured with: QoLI; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	33	-	MD 0.41 higher (0.34 lower to 1.16 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life (follow-up 12 months; measured with: QoLI; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	31	-	MD 0.64 higher (0.11 lower to 1.39 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Anxiety (follow-up 8 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	33	-	MD 0.46 higher (0.97 lower to 1.89 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up 12 months; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	30	31	-	MD 1.49 lower (3.48 lower to 0.5 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up 8 weeks; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	30	33	-	MD 0.11 lower (1.54 lower to 1.32 higher)	⨁⨁◯◯ LOW	IMPORTANT
Depression (follow-up 12 months; measured with: HADS; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	30	31	-	MD 1.96 lower (3.55 to 0.37 lower)	⨁⨁◯◯ LOW	IMPORTANT
Sleep (follow-up 8 weeks; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	30	33	-	MD 1.45 higher (1.62 lower to 4.52 higher)	⨁⨁◯◯ LOW	IMPORTANT
Sleep (follow-up 12 months; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	30	31	-	MD 5.29 lower (9.88 to 0.7 lower)	⨁⨁◯◯ LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 55Clinical evidence profile: Biofeedback versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Biofeedback	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus distress (follow-up 8 weeks; measured with: Tinnitus diary; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	20	-	MD 1.33 lower (9.77 lower to 7.11 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus distress (follow-up 6 months; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	19	-	MD 3.29 lower (14.15 lower to 7.57 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life (follow-up 6 months; measured with: Health Life Satisfaction; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	19	-	MD 7.47 higher (17.67 lower to 32.61 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life (follow-up 8 weeks; measured with: Health Life Satisfaction; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	22	20	-	MD 0.54 higher (20.48 lower to 21.56 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up 8 weeks; measured with: Tinnitus diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	20	-	MD 0.49 lower (1.43 lower to 0.45 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up 6 months; measured with: Tinnitus diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	22	19	-	MD 0.17 higher (0.96 lower to 1.3 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 56Clinical evidence profile: Biofeedback-based CBT versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Biofeedbackbased CBT	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up 3 months; measured with: Global severity index of SLC-90-R; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	52	59	-	MD 0.01 lower (0.21 lower to 0.19 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus distress (follow-up 3 months; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	52	59	-	MD 17.02 lower (22.6 to 11.44 lower)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus distress (follow-up 3 months; measured with: Tinnitus diary; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	52	59	-	MD 1.04 lower (1.68 to 0.4 lower)	⨁⨁◯◯ LOW	CRITICAL
Tinnitus loudness (follow-up 3 months; measured with: Tinnitus diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	52	59	-	MD 1.33 lower (1.98 to 0.68 lower)	⨁⨁◯◯ LOW	IMPORTANT
Depression (follow-up 3 months; measured with: BDI; range of scores: 0-63; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	52	59	-	MD 1.09 lower (4.16 lower to 1.98 higher)	⨁⨁◯◯ LOW	IMPORTANT
Sleep (follow-up 3 months; measured with: Sleep disturbance diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	serious¹	no serious inconsistency	no serious indirectness	serious²	none	52	59	-	MD 1.37 lower (2.28 to 0.46 lower)	⨁⨁◯◯ LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 57Clinical evidence profile: Behavioural therapy versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Behavioural therapy	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus loudness (direct) (follow-up post-treatment; measured with: Diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	12	-	MD 0.96 lower (2.49 lower to 0.57 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (retrospective) (follow-up post-treatment; measured with: Diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	12	-	MD 1.01 lower (2.80 lower to 0.78 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus annoyance (retrospective) (follow-up post-treatment; measured with: Diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	12	-	MD 0.55 lower (1.67 lower to 0.57 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (retrospective) (follow-up post-treatment; measured with: Diary; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	12	12	-	MD 0.92 lower (1.93 lower to 0.09 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Mindfulness-based therapies

Table 58Clinical evidence profile: Mindfulness-based cognitive therapy versus relaxation

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Mindfulness-based cognitive therapy	Relaxation	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	36	32	-	MD 6.8 lower (14.03 lower to 0.43 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus severity (follow-up 6 months; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	34	28	-	MD 7.6 lower (16.3 lower to 1.1 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus severity (follow-up post-treatment; measured with: TFI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	36	32	-	MD 7.00 lower (16.09 lower to 2.09 higher)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus severity (follow-up 6 months; measured with: TFI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	34	28	-	MD 11.80 lower (23.06 to 0.54 lower)	⨁⨁⨁◯ MODERATE	CRITICAL
Tinnitus loudness (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	36	32	-	MD 2.6 lower (13.94 lower to 8.74 higher)	⨁⨁⨁◯ MODERATE	IMPORTANT
Tinnitus loudness (follow-up 6 months; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	34	28	-	MD 10.3 lower (23.79 lower to 3.19 higher)	⨁⨁⨁◯ MODERATE	IMPORTANT
Depression (follow-up post-treatment; measured with: HADS/ BDI; range of scores: 0-21, 0-63; Better indicated by lower values)
2	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	49	44	-	SMD 0.41 lower (0.82 lower to 0.01 higher)	⨁⨁⨁◯ MODERATE	IMPORTANT
Depression (follow-up 6 months; measured with: HADS/BDI; range of scores: 0-21, 0-63; Better indicated by lower values)
2	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	47	40	-	SMD 0.42 lower (0.85 lower to 0.01 higher)	⨁⨁⨁◯ MODERATE	IMPORTANT
Anxiety (follow-up post-treatment; measured with: HADS/STRAI; range of scores: 0-21, 20-80; Better indicated by lower values)
2	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	no serious imprecision	none	49	44	-	SMD 0.24 lower (0.65 lower to 0.17 higher)	⨁⨁⨁⨁ HIGH	IMPORTANT
Anxiety (follow-up 3-6 months; measured with: HADS/ STRAI; range of scores: 0-21, 20-80; Better indicated by lower values)
2	randomised trials	no serious risk of bias	no serious inconsistency	no serious indirectness	serious¹	none	47	40	-	SMD 0.39 lower (0.82 lower to 0.03 higher)	⨁⨁⨁◯ MODERATE	IMPORTANT

1: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 59Clinical evidence profile: Mindfulness meditation versus relaxation therapy

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Mindfulness meditation	Relaxation therapy	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up mean 15 weeks; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	34	27	-	MD 1.5 lower (2.51 to 0.49 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus loudness (follow-up mean 15 weeks; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious¹	none	34	27	-	MD 0.64 lower (1.79 lower to 0.51 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up mean 15 weeks; measured with: HADS - anxiety; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	34	27	-	MD 1.3 lower (3.08 lower to 0.48 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up mean 15 weeks; measured with: HADS - depression; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	34	27	-	MD 0.33 lower (2.07 lower to 1.41 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression and anxiety (follow-up mean 15 weeks; measured with: HADS - total; range of scores: 0-42; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	very serious²	none	34	27	-	MD 1.63 lower (4.94 lower to 1.69 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 60Clinical evidence profile: Mindfulness and body psychotherapy-based group treatment versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Mindfulness and body-psychotherapy-based group treatment	Waiting-list control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: TQ; range of scores: 0-84; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	15	16	-	MD 6.6 lower (18.18 lower to 4.98 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus severity (follow-up post-treatment; measured with: THI; range of scores: 0-1-; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	15	16	-	MD 14 lower (28.43 lower to 0.43 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Tinnitus annoyance (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	15	16	-	MD 1.8 lower (3.6 lower to 0 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Tinnitus loudness (follow-up post-treatment; measured with: VAS; range of scores: 0-10; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	15	16	-	MD 1.9 lower (3.67 to 0.13 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Depression (follow-up post-treatment; measured with: BDI; range of scores: 0-63; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	15	16	-	MD 5.7 lower (10.85 to 0.55 lower)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Acceptance and commitment therapy (ACT)

Table 61Clinical evidence profile: iACT versus control (web discussion forum)

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	iACT	Control (web discussion forum)	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity and distress (follow-up post-treatment; measured with: THI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	no serious imprecision	none	33	32	-	MD 18 lower (25.46 to 10.54 lower)	⨁⨁◯◯ LOW	CRITICAL
Quality of life (follow-up post-treatment; measured with: QoLI; Better indicated by higher values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	33	32	-	MD 0.15 lower (0.87 lower to 0.57 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: HADS - depression; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious¹	none	33	32	-	MD 1.11 lower (2.52 lower to 0.3 higher)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: HADS - anxiety; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	33	32	-	MD 2.57 lower (4.15 to 0.99 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep (follow-up post-treatment; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	33	32	-	MD 2.74 lower (5.78 lower to 0.3 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 62Clinical evidence profile: ACT versus waiting-list control

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	ACT	Waiting-list Control	Relative (95% CI)	Absolute	Quality	Importance
Tinnitus severity (follow-up post-treatment; measured with: THI; range of scores: 0-100; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	22	-	MD 20.86 lower (32.76 to 8.96 lower)	⨁◯◯◯ VERY LOW	CRITICAL
Quality of life ((follow-up post-treatment; measured with: QoLI; Better indicated by higher values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	22	-	MD 0.86 higher (0.12 lower to 1.84 higher)	⨁◯◯◯ VERY LOW	CRITICAL
Depression (follow-up post-treatment; measured with: HADS- depression; range of scores: 0-21; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	22	-	MD 3 lower (5.59 to 0.41 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Anxiety (follow-up post-treatment; measured with: HADS - anxiety; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	22	-	MD 3 lower (5.59 to 0.41 lower)	⨁◯◯◯ VERY LOW	IMPORTANT
Sleep ((follow-up post-treatment; measured with: ISI; range of scores: 0-28; Better indicated by lower values)
1	randomised trials	very serious¹	no serious inconsistency	no serious indirectness	serious²	none	22	22	-	MD 2.55 lower (5.9 lower to 0.8 higher)	⨁◯◯◯ VERY LOW	IMPORTANT

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Appendix G. Health economic evidence selection

Figure 165Flow chart of health economic study selection for the guideline

* Non-relevant population, intervention, comparison, design or setting; non-English language

Appendix H. Health economic evidence tables

Download PDF (198K)

Appendix I. Excluded studies

I.1. Excluded clinical studies

Table 63Studies excluded from the clinical review

Study	Exclusion reason
Andersson 1999⁴	Incorrect study design: non-randomised study
Andersson 2015³	Incorrect study design: literature review
Beukes 2015¹²	Incorrect study design: study protocol
Beukes 2017¹⁰	Incorrect study design: study protocol
Beukes 2018¹¹	No relevant outcome data
Beukes 2018 ¹³	Incorrect study design: non-randomised study
Beukes 2018⁸	Incorrect study design: non-randomised study
Caffier 2006¹⁴	No relevant outcome data
Cima 2014¹⁵	Incorrect study design: systematic review including non-randomised studies
Cima 2017¹⁷	Incorrect study design: secondary analysis of an RCT with no relevant outcome data
Hesser 2014²³	No relevant outcomes
Hiller 2005 ²⁴	Incorrect study design: non-randomised study
Jakes 1992²⁵	No relevant outcomes
Kaldo 2008²⁸	Incorrect comparison: two types of CBT
Kallogjeri 2017²⁹	Incorrect population: control group in study is people without tinnitus
Kleinstauber 2018³⁰	Incorrect study design: non-randomised study
Krings 2015³²	Incorrect intervention: pharmacological intervention
Malinvaud 2016³⁸	Incorrect comparison: CBT versus auditory and visual 3D virtual reality therapy
Marks 2019⁴⁰	Incorrect study design: non-randomised study
Martz 2018⁴¹	No relevant outcome data
Mason 1994⁴²	Incorrect study design; incorrect intervention: hypnotherapy
Mason 1996⁴³	Incorrect comparison: counselling versus hypnotherapy
Maudoux 2007⁴⁴	Incorrect study design: non-randomised study
McCombie 2015⁴⁵	Incorrect population: people with physical illnesses (tinnitus not a specific population within study)
McKenna 2018⁴⁷	Incorrect study design: non-randomised study
Nyenhuis 2013⁴⁹	Incorrect study design: secondary analysis of an RCT with no relevant outcome data
Robinson 2008⁵⁴	Data not extractable
Thompson 2017⁵⁶	Incorrect study design: non-randomised study
Tyler 2007⁵⁷	Incorrect study design: narrative article
Weise 2005⁶¹	Not English Language
Weise 2007⁵⁸	Not English language
Zachriat 2003⁶³	Not available
Zarenoe 2016⁶⁵	Incorrect intervention: included in combination review
Zenner 2013⁶⁶	Incorrect study design: non-randomised study
Zhong 2014⁶⁷	Not English Language
Zoeger 2008⁶⁸	Incorrect study design: non-randomised study

I.2. Excluded health economic studies

Table 64Studies excluded from the health economic review

Reference	Reason for exclusion
Kaldo 2007²⁷	This study was assessed as partially applicable with very serious limitations as the authors only include resource use rather than costs.
Kaldo 2008²⁸	This study was assessed as partially applicable with very serious limitations as the authors only include resource use rather than costs.

Appendix J. Research recommendations

Cognitive behavioural therapy (CBT) for adults with tinnitus delivered by appropriately trained healthcare professionals other than psychologists

Research question: What is the clinical and cost effectiveness of CBT for adults with tinnitus delivered by appropriately trained healthcare professionals other than psychologists (for example, audiologists)?

Why this is important:

CBT is a psychological therapy that is usually delivered to individuals with tinnitus by psychologists. However, individuals who present with tinnitus commonly see non-psychologists (e.g. audiologists) and there are many more non-psychologists than psychologists working in the tinnitus field. Costs could be reduced and access to CBT could be improved if appropriately trained non-psychologists were able to deliver CBT. There is currently insufficient evidence to recommend this.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults (aged over 18 years old) presenting with tinnitus Intervention(s): CBT (individual, group and digital) delivered by non-psychologists (e.g. audiologists). Comparison: CBT delivered by psychologists Sound therapy and sound enrichment sound enrichment (e.g. environmental sound, a CD or mp3 download or the radio, a smartphone App, bedside/table-top sound generators, a wearable sound generator) Combination hearing devices (hearing aid combined with sound generator) Customised sound-based therapies, e.g. amplitude modulated tones, notched noise/music Masking Tinnitus support, intervention involving the following components: Discussion of experience of tinnitus, including any concerns and its impact with individuals presenting with tinnitus. This discussion occurs between the person with tinnitus or their family members or carers and healthcare professional. A management plan is also developed to include information and opportunities for discussion about different management options Amplification devices for those with a hearing loss Hearing aids Implantable devices (including cochlear implants, bone-anchored hearing aids, bone-conduction hearing implants, bone-bridge/middle-ear devices) Combination device (sound generator and hearing aids) No psychological therapy Outcome(s): Tinnitus severity (critical)- measured using validated questionnaires Impact of tinnitus, measured using validated questionnaires:(critical) Tinnitus Distress Tinnitus Annoyance Health related QoL, measured using validated questionnaires: (critical) QoL (EQ-5D) Tinnitus percept, measured using validated questionnaires: Tinnitus Loudness (important) Other co-occurring complaints, measured using validated questionnaires (important) Depression Anxiety Anxiety and depression Sleep NHS costs and cost effectiveness
Importance to patients or the population	There is evidence that CBT is helpful in the management of tinnitus. The evidence comes from studies where the therapy is delivered by psychologists. There are, however, very few psychologists working in the field. Most people complaining of tinnitus will be managed by other health care professionals, usually audiologists. CBT is not a part of the routine training of audiologists and few have taken additional training. This means that a lot of people seeking help for tinnitus are unable to access this successful management option. The situation is analogous to the historic lack of access to CBT for mental health problems. If CBT for tinnitus can be successfully delivered by audiologists with appropriate training and supervision, then people complaining of tinnitus will be able to access treatment. Demonstration of cost effectiveness is crucial and trials will need to consider the supervision level required by non-psychologists and psychologists to provide a cost - effective service.
Relevance to NICE guidance	Evidence in this area may mean that future NICE guidance recommends that CBT is carried out by suitably trained professionals, other than psychologists, allowing wider access to this intervention.
Relevance to the NHS	If CBT delivered by audiologists is shown to be cost- effective, audiologists delivering tinnitus services would need additional training. If CBT by audiologists is not shown to be effective, strategic planning would be required to allow for increased inclusion of psychologists in tinnitus services.
National priorities	None.
Current evidence base	One UK based RCT (Beukes 2018)⁹; the CBT intervention was delivered by audiologists with supervision from a psychologist. However, this study was an internet-delivered approach which is not available clinically. It exists only for use in research and is therefore not applicable to the question. There is no evidence that considers face-to-face CBT delivered by audiologists. CBT has been shown to be effective for tinnitus when carried out by psychologists but access to psychology services are limited in most parts of the country.
Equality	None.
Study design	Randomised controlled trial examining cost effectiveness outcomes. It may be possible to have a single blinding in the RCT. In theory participant might be blinded to the profession of the therapists. However the accessibility of professional profiles on social media and institutional websites may limit this.
Feasibility	The study is feasible and could be carried out in a reasonable timescale.
Other comments	None.
Importance	High: the research is essential to inform future updates of key recommendations in the guideline.

J.1. Psychological therapies for children and young people

Research question: What is the clinical and cost effectiveness of psychological therapies for children and young people who have tinnitus-related distress?

Why this is important:

The clinical and cost effectiveness of psychological therapies has been a focus of research in the management of tinnitus for adults and this has been used to determine the current guidelines. Currently there is no research looking at this for children and recommendations are limited in not being able to recommend specific psychological approaches. This will be important for children with tinnitus and their families so that they are able to receive the best care, and for care providers so that they can provide the most clinical and cost effective care.

Criteria for selecting high-priority research recommendations

PICO question	Population: Children and young people presenting with tinnitus Intervention(s): Psychological therapies Cognitive Behavioural therapy (CBT) Mindfulness-based interventions e.g. Cognitive therapy and MBSR Brief solution focused therapy Narrative therapy Family therapy/Systemic therapy Comparison: Interventions compared with each other Interventions in combination with each other Sound therapy and sound enrichment sound enrichment (e.g. environmental sound, a CD or mp3 download or the radio, a smartphone App, bedside/table-top sound generators, a wearable sound generator) Combination hearing devices (hearing aid combined with sound generator) Customised sound-based therapies Masking Tinnitus support, intervention involving the following components: Discussion of experience of tinnitus, including any concerns and its impact with individuals presenting with tinnitus. This discussion occurs between the person with tinnitus or their family members or carers and healthcare professional. A management plan is also developed to include information and opportunities for discussion about different management options Amplification devices for those with hearing loss Hearing aids Implantable devices (including cochlear implants, bone-anchored hearing aids, bone-conduction hearing implants, bone-bridge/middle-ear devices) Combination device (sound generator and hearing aids) No psychological therapy Waiting-list control Outcome(s): Tinnitus severity (critical) Impact of tinnitus:(critical) Tinnitus Distress Tinnitus Annoyance Health related QoL (critical): QoL (EQ-5D) Tinnitus percept: Tinnitus Loudness (important) Other co-occurring complaints (important) Depression Anxiety Anxiety and depression Sleep
Importance to patients or the population	The question is important to children, young people and their families who experience tinnitus distress as there are few management options available for children and young people.
Relevance to NICE guidance	The answer to this question would inform future NICE guidance as to the clinical and cost effectiveness of psychological therapies for children and young people.
Relevance to the NHS	There is no practice in the UK for children and young people as there is no evidence of clinical or cost effectiveness. There is a need for evidence to inform future recommendations.
National priorities	There is Department of Health/NHS England guidance on ‘Improving mental health services for young people’: ‘Future in mind. Promoting, protecting and improving our children and young people’s mental health and wellbeing (2015)’ (https://www.gov.uk/government/publications/improving-mental-health-services-for-young-people). This is the report of the work of the Children and Young People’s Mental Health Taskforce.
Current evidence base	No evidence was identified that evaluated the use of psychological therapies for children and young people with tinnitus.
Equality	Currently, research has only been carried out with adults and therefore this question will address equality issues in being able to make recommendations for children and young people. Research should consider children of different ages and abilities.
Study design	Randomised control trial with a good quality control group. A robust qualitative study could be an alternative.
Feasibility	There are few providers of psychological services for children with tinnitus.
Other comments	Any intervention for tinnitus for children and young people should consist of the systematic working of healthcare professionals with children and young people and their parents, carers and teachers.
Importance	High: the research is essential to inform future updates of key recommendations in the guideline.

J.2. Psychological therapies for people who are d/Deaf or who have a severe-to-profound hearing loss

Research question: What is the clinical and cost effectiveness of psychological therapies for people who are d/Deaf or who have a severe-to-profound hearing loss and tinnitus-related distress?

Why this is important:

Psychological therapies, also known as “talking therapies”, may be difficult to access for those who have a severe-to-profound hearing loss particularly those who communicate through British Sign Language and/or rely on lip reading despite amplification. This question seeks to identify the effective types or delivery modes of psychological therapies for such individuals.

Criteria for selecting high-priority research recommendations

PICO question	Population: Children, young people and adults presenting with tinnitus-related distress who are d/Deaf or who have a severe-to-profound hearing loss including those who communicate by British Sign Language (BSL) Intervention(s): Psychological therapies Cognitive Behavioural therapy (CBT) Mindfulness-based interventions e.g., Cognitive therapy and MBSR Brief solution focused therapy Narrative therapy Family therapy/Systemic therapy Comparison: Interventions compared with each other Interventions in combination with each other Sound therapy Combination hearing devices (hearing aid combined with sound generator) Customised sound-based therapies Tinnitus support including coping strategies, provision of information and advice and relaxation Amplification devices for those with hearing loss Hearing aids Implantable devices (including cochlear implants, bone-anchored hearing aids, bone-conduction hearing implants, bone-bridge/middle-ear devices) Combination device (sound generator and hearing aids) No psychological therapy Waiting-list control Outcome(s): Tinnitus severity (critical) Impact of tinnitus:(critical) Tinnitus Distress Tinnitus Annoyance Health related QoL (critical): QoL (EQ-5D) Tinnitus percept: Tinnitus Loudness (important) Other co-occurring complaints (important) Depression Anxiety Anxiety and depression Sleep
Importance to patients or the population	There is currently very limited research into how to manage tinnitus in people who are D/deaf and therefore no clinical evidence or guidance on how to do so. Tinnitus is co-morbid with hearing loss and so understanding how to manage tinnitus within this population should be a priority, as standard care is not feasible for people who are D/deaf.
Relevance to NICE guidance	It would help to ensure future guidance is relevant to a key group for whom tinnitus is an issue and who are identified as such within the equality impact assessment.
Relevance to the NHS	This may impact on strategic delivery or service delivery depending on findings. In the SignHealth Report of 2014, ‘Sick of it: how the health service is failing deaf people’(https://www.signhealth.org.uk/health-information/sick-of-it-report/), it was pointed out that deaf people have worse health and lower life expectancy than people who are not deaf. It is important to find evidence to help reduce this inequality.
National priorities	N/A
Current evidence base	No evidence was identified that evaluated psychological therapies in people presenting with tinnitus-related distress who are d/Deaf or who have a severe-to-profound hearing loss
Equality	This research recommendation addresses people with who are d/Deaf or who have a severe-to-profound hearing loss, a group that needs special consideration.
Study design	Randomised controlled trial or well-designed prospective or retrospective cohort study.
Feasibility	Limited availability to mental health services for those who communicate by BSL. Those who do not use BSL, interpreter will be needed.
Other comments	Psychological therapies could be delivered by BSL.
Importance	Low: the research is of interest and will fill existing evidence gaps.

Figures

Figure 1Sensitivity analysis of mean cost per patient for each psychological therapy strategy

Diamonds indicate base case analysis estimates

Tables

Table 1PICO characteristics of review question

Population	Children, young people and adults with tinnitus. Strata: Children/young people (up to 18 years) and adults
Intervention(s)	Psychological therapies Cognitive Behavioural therapy (CBT) Mindfulness-based interventions e.g. cognitive therapy and MBSR Brief solution focused therapy Narrative therapy Family therapy/Systemic therapy Acceptance and commitment therapy (ACT) EMDR
Comparison(s)	Interventions compared with each other Interventions in combination with each other Control group (i.e. no psychological therapy) Sound therapy and sound enrichment sound enrichment (e.g. environmental sound, a CD or mp3 download or the radio, a smartphone App, bedside/table-top sound generators, a wearable sound generator) Combination hearing devices (hearing aid combined with sound generator) Customised sound-based therapies, e.g. amplitude modulated tones and notched noise/music Masking Tinnitus education including coping strategies, provision of information and advice and relaxation Amplification devices Hearing aids Implantable devices (including cochlear implants, bone-anchored hearing aids, bone-conduction hearing implants, bone-bridge/middle-ear devices) Combination device (sound generator and hearing aids)
Outcomes	Tinnitus severity (critical) Impact of tinnitus (critical): Tinnitus distress Tinnitus annoyance Health related QoL (critical): QoL (tinnitus) QoL Tinnitus percept (important): Tinnitus loudness Other co-occurring complaints (important): Depression Anxiety Anxiety and depression Sleep Adverse events (important): Safety Tolerability Side effects
Study design	Systematic review of RCTs RCT If there is an inadequate amount of RCT data, non-randomised comparative studies will be considered

Table 2Summary of studies included in the evidence review

Study

Intervention and comparison

Population

Outcomes

Comments

Abbott 2009 ¹

RCT

Intervention (n=32):

Cognitive behavioural therapy (CBT) (internet-based) – intervention consisted of 10 components, presented in six modules – one module per week (intervention lasted 6 weeks). Sessions included applied relaxation training, information about noise sensitivity, sleep management.

Comparison (n=24):

Information only – participants read the online tinnitus information program. This program consisted of psychoeducational information minus active CBT components. Intervention was delivered over 6 weeks. Participants were provided option of completing the CBT intervention after 6 weeks.

n=56

People presenting with tinnitus for at least 3 months

Age (mean): 49.6 years

Gender (male to female ratio): 8.1:1

Duration of tinnitus (mean): 100 months

Australia

Tinnitus distress (follow-up: post-treatment): measured using the Tinnitus Reaction Questionnaire, scale range not reported (according to literature it is 0-104)

Tinnitus annoyance (follow-up: post-treatment): measured using a visual analogue scale (VAS), scale range 0-10

Tinnitus loudness (follow-up: post-treatment): measured using a visual analogue scale (VAS), scale range 0-10

Depression (follow-up: post-treatment): measured using the Depression, Anxiety and Stress Scale (DASS), scale range not reported (according to literature it is 0-120)

Anxiety (follow-up: post-treatment): measured using the Depression, Anxiety and Stress Scale (DASS), scale range not reported (according to literature it is 0-120)

Sleep quality (follow-up: post-treatment): measured using a visual analogue scale (VAS), scale range 0-10

Andersson 2002⁶

RCT

Intervention (n=53):

Internet cognitive behavioural self-help treatment. A self-help manual was constructed using cognitive behavioural principles. Components were presented in 6 modules on a weekly basis for 6 weeks. This included applied relaxation, positive imagery, sound enrichment by means of external sounds, hearing tactics, and advice regarding noise sensitivity, controlled breathing and cognitive therapy, which was adjusted to deal with negative thoughts and beliefs relating to tinnitus, sleep management, exercises of concentration (mindfulness), and advice on physical activity. 6 weeks duration.

Comparison (n=64):

Waiting list control. The participants were informed that they had been randomised to a waiting-list condition and were offered the program 6 weeks later.

n=117

People presenting with tinnitus for at least 6 months, tinnitus was a severe problem for the participants

Age (mean): iCBT group: 48.5 years; WL group: 47.2 years

Gender (male to female ratio): 55/62

Duration of tinnitus: iCBT group: 6.2 (5.6); WL group: 6.4 (6.8)

Sweden

Tinnitus annoyance (follow-up: post-treatment): measured using a VAS, scale range 0-10

Tinnitus loudness (follow-up: post-treatment): measured using a VAS, scale range 0-10

Sleep quality (follow-up: post-treatment): measured using a VAS, scale range 0-10

Depression (follow-up: post-treatment and 1 year): measured using HADS – depression, scale range 0-21

Anxiety (follow-up: post-treatment and 1 year): measured using HADS – anxiety, scale range 0-21

Andersson 2005⁵

RCT

Intervention (n=12):

Cognitive behavioural therapy (CBT) – six group sessions consisting of information about tinnitus, applied relaxation (presented during four sessions), cognitive restructuring, behavioural activation, positive imagery, sound enrichment, exposure to tinnitus, advice regarding hyperacusis, hearing tactics and relapse prevention. Intervention lasted for five weeks.

Comparison (n=11):

Waiting-list control – participants in this group did not receive the intervention until about five weeks. Participants were then given shortened version of the version (four sessions instead of six sessions)

n=23

People presenting with bothersome tinnitus (tinnitus that is audible in many acoustic environments, disturbs sleep, or is a dominating problem that affects quality of life) for at least 6 months

Age (mean): 70.1 years

Gender (male to female ratio): 1.1:1

Duration of tinnitus (mean): 13 years

Sweden

Tinnitus distress (follow-up: 3 months): measured using the Tinnitus Reaction Questionnaire (TRQ), scale range 0-104

Depression (follow-up: 3 months): measured using the Hospital Anxiety and Depression Scale (HADS) (depression subscale used), scale range not reported (according to literature it is 0-21)

Anxiety (follow-up: 3 months): measured using the Hospital Anxiety and Depression Scale (HADS) (depression subscale used), scale range not reported (according to literature it is 0-21)

Anxiety (follow-up: 3 months): measured using the Anxiety Sensitivity Index (ASI), scale range not reported

Arif 2017⁷

RCT

Intervention (n= 42):

Mindfulness meditation: treatment plans standardised in a session format, which included the following topics: exploration, sitting meditation, meditation applied and reviewed. 5 face-to-face sessions of 40 minutes over 15 weeks

Comparison (n=44):

Relaxation therapy sessions split between two experienced therapists who followed a manual. A session format was followed, including the following topics: exploration, mental skill development, cue-controlled relaxation, differential relaxation, rapid relaxation application and review of subjective findings. 5 face-to-face relaxation therapy sessions of 40 minutes over 15 weeks.

n=86

People presenting with ‘intrusive’ tinnitus

Age (mean): 53.8 years in mindfulness group;58.3 years in relaxation group

Gender (male to female ratio): 1:1.2

Duration of tinnitus (range): 6 months -15 years

United Kingdom

Tinnitus severity (post treatment): measured using a VAS, scale range 0-10.

Tinnitus loudness (post treatment): measured using a VAS, scale range 0-10.

Anxiety (post treatment): measured using HADS – Anxiety, scale range 0-21.

Depression (post treatment): measured using HADS – Depression, scale range 0-21.

Depression and anxiety (post treatment): measured using HADS – total, scale range 0-42.

Beukes 2018⁹

RCT

Intervention (n=46):

Cognitive behavioural therapy (CBT) (internet-based) - based on a CBT self-help program adapted into an 8-week program consisting of 16 recommended modules and 5 optional modules. A minimum of 10 minutes of asynchronous audiologist guidance was provided to participants.

Comparison (n=46):

Tinnitus information counselling – participants attended an initial appointment (60 minutes) to provide explanations about tinnitus and some basic management strategies. Participants also received additional strategies for tinnitus management, including sleep hygiene, relaxation strategies, and negative thought analysis during follow-up.

n=92

People presenting with bothersome tinnitus

Age (mean): 52.96 years

Gender (male to female ratio): 1.49:1

Duration of tinnitus: 6.54 years

United Kingdom

Tinnitus severity (follow-up: post-treatment and 2 months): measured using Tinnitus Handicap Inventory (THI), scale range 0-100

Tinnitus distress (follow-up: post-treatment and 2 months): measured using Tinnitus Functional Index (TFI), scale range 0-100

Quality of life (follow-up: post-treatment and 2 months): measured using the Satisfaction With Life Scales (SWLS), scale range 5-35

Depression (follow-up: post-treatment and 2 months): measured using the Patient Health Questionniare-9 (PHQ-9), scale range 0-27

Anxiety (follow-up: post-treatment and 2 months): measured using the Generalised Anxiety Disorder-7 (GAD-7), scale range 0-21

Sleep (follow-up: post-treatment and 2 months): measured using the Insomnia Severity Index (ISI), scale range 0-28

Cima 2012¹⁶

RCT

Intervention (n=245):

Specialised stepped intervention based on CBT – all participants allocated to this intervention received step 1 which consisted of multidisciplinary diagnostics and specific tinnitus retraining counselling (undertaken in a cognitive behaviour framework). Participants with mild complaints received step 1 of the intervention. Step 1 lasted for 3 months. Participants who had severe tinnitus entered step 2, consisting of three different 12-week group treatment options.

Comparison (n=247):

Usual care – all participants received a standard audiological intervention (step 1). Participants who had severe tinnitus entered step 2 which involved interactions with a social worker.

n=492

People presenting with subjective tinnitus

Age (mean): 54.19 years

Gender (male to female ratio): 1.7:1

Duration of tinnitus: <1 year – 30%; 1-5 years – 39%; >5 years – 31%

Netherlands

Tinnitus severity (follow-up: 3 months and 12 months): measured using Tinnitus Questionnaire, total score ranges not reported (0-84 as indicated in literature)

Quality of life (follow-up: 3 months and 12 months): measured using the Health Utilities Index (HUI) mark 3, total score ranges from - 0.36-1

Tinnitus-related quality of life (follow-up: 3 months and 12 months): measured using the Tinnitus Handicap Inventory, total score ranges 0-100

Depression and anxiety (follow-up: 3 months and 12 months): measured using the Hospital Anxiety and Depression Inventory, total score ranges 0-42

Davies 1995¹⁹

RCT

Intervention 1 (n=16):

Cognitive behavioural therapy - intervention explored the meaning of tinnitus with the subject and identified any negative thoughts associated with emotional distress, which were then related to broader beliefs or underlying assumptions. The therapist aided this by completing a checklist with the client which listed common tinnitus complaints, associated emotions, and commonly held maladaptive beliefs about tinnitus. 6 one hour sessions with possible extension to 8 sessions.

Intervention 2 (n=13):

Passive relaxation training (PRT). It was explained to participants how PRT would break into the vicious cycle of “annoyance-stress-attention to noises-further annoyance” by diminishing the stress response to tinnitus annoyance. Relaxation was taught in a sitting or lying position in the office and included: progressive muscle tensing/relaxing use of pleasant visual imagery to promote mental calmness; and encouragement of relaxed diaphragmatic breathing. 6 one hour sessions with possible extension to 8 sessions.

Intervention 3 (n=16):

Applied Relaxation Training (ART). Relaxation was taught as the PRT and additionally explained that acquisition of the skill through daily practice would break into the vicious cycle of “annoyance to greater attention to greater annoyance” by enabling subjects to apply relaxation when tinnitus was annoying. 6 one hour sessions with possible extension to 8 sessions.

n=45

People presenting with tinnitus for at least 6 months, tinnitus was a significant problem for the participants

Age (mean): 56.3 years

Gender (male to female ratio): 1:1.3 (completers)

Duration of tinnitus (range): 6 months -6 years

United Kingdom

Tinnitus distress (follow-up: post-treatment and 4 months): measured using TEQ scales – emotional distress, scale range not reported

Tinnitus loudness (follow-up: post-treatment and 4 months): measured using tinnitus loudness rating, scale 1-5

Tinnitus annoyance (follow-up: post treatment and 4 months): measured using tinnitus annoyance rating, scale range not reported

Anxiety (follow-up: 1 month): measured using STAI, scale ranges from 20-80

Depression (follow-up:1 month): measured using BDI, scale ranges from 0-63

Insomnia (follow-up: post-treatment and 4 months): measured using TEQ- insomnia, scale range not reported

Henry 1996²¹

RCT

Intervention 1 (n=20):

Cognitive behavioural therapy (CBT) – cognitive therapy in which participants were encouraged to learn to approach the problem of tinnitus in more adaptive and constructive way in small group sessions. Participants were trained in attention diversions strategies, imagery training (including mental imagery). Participants received a written manual containing educational material and techniques. Intervention involved one 90-minute session for six weeks.

Intervention 2 (n=20):

Education counselling (group-based intervention) – purpose was to educate participants about tinnitus. Session topics included: the auditory system, causes of tinnitus, theories of tinnitus and medical treatments. One small group 90-minute session per week for 6 weeks.

Comparison (n=20):

Waiting-list control – participants were informed that their participation would be delayed.

n=60

People presenting with chronic tinnitus and tinnitus distress for at least 6 months

Age (mean): 64.6 years

Gender (male to female ratio): 6.5:1

Duration of tinnitus: Not reported

Australia

Tinnitus distress (follow-up: post-treatment and 12 months: measured using the Tinnitus Reaction Questionnaire (TRQ), scale ranges from 0-104

Tinnitus annoyance (follow-up: post-treatment and 12 months): measured using visual analogue scale range 0-4 (unclear)

Tinnitus related quality of life (follow-up: post-treatment and12 months): measured using the Tinnitus Handicap Questionnaire (THQ). Participants assign a number between 0 (strongly disagree) -100 (strongly agree), total score is divided by 28 (28-item questionnaire)

Tinnitus loudness (follow-up: post-treatment and 12 months): measured using visual analogue scale range 0-4

Depression (follow-up: post-treatment and 12 months): measured using the Beck Depression Inventory (BDI), scale ranges from 0-63

Included in counselling review

Waiting-list control groups also received cognitive therapy after 6 weeks. 12 month follow-up results for this group were for after treatment had been completed

Hesser 2012²²

RCT

Intervention 1 (n=32):

Internet-delivered CBT -guided, internet-delivered therapy, including structured self-help material via the internet and an identified therapist for support and guidance by email. Involved tinnitus-specific CBT techniques including applied relaxation, positive imagery, attention training, cognitive restructuring, exposure, and the use of background sounds to cope with the experience of tinnitus. Intervention was 8 weeks long.

Intervention 2 (n=35):

Internet-delivered ACT– guided, internet-delivered therapy, including structured self-help material via the internet and an identified therapist for support and guidance by email. Involved tinnitus-specific ACT including exercises that focused on mindfulness and distancing of internal experiences (i.e. defusion), assignments with the purpose of identifying personal values and goals and exercises that promoted willingness to experience tinnitus in the context of value-based behaviour change. Intervention was 8 weeks long.

Comparison (n=32):

Web discussion forum – confidential moderated online discussion forum that specifically targeted tinnitus-related problems. Participants were encouraged to take part in the forum, each week a therapist posted a new topic to discuss and monitored the forum. Intervention was 8 weeks long.

n=99

People presenting with tinnitus for 6 months or more with diagnosis confirmed, participants had ‘moderate to severe’ tinnitus distress

Age (mean): 48.5 years

Gender (male to female ratio): 1.1/1

Duration of tinnitus: 8.9 months in iCBT group; 9.7months in ACT group; 9 months in control group

Sweden

Tinnitus distress and severity (follow-up, post-treatment and at 1 year), measured by THI, scale range 0-100.

Quality of life (follow-up, post-treatment and at 1 year), measured by Quality of Life Inventory, scale range: not reported

Depression (follow-up, post-treatment and at 1 year), measured by HADS depression, scale range 0-21

Anxiety (follow-up post-treatment and at 1 year), measured by HADS-anxiety, scale range: 0-21

Sleep (follow-up, post-treatment and at 1 year), measured by Insomnia Severity Index, scale range: 0-28

It should be noted that iCBT or ACT compared to the control group was only followed up to 8 weeks, and not to 1 year, whereas iCBT versus iACT was followed up additionally to 1 year.

Jasper 2014²⁶

RCT

Intervention 1 (n=41):

Internet cognitive behavioural therapy (iCBT). 12 mandatory and 6 optional text modules, each covering a particular topic, including: applied relaxation, positive imagery, focus exercises, exposure to tinnitus; cognitive restructuring; avoidance behaviour. Once a week patients could communicate with the therapist via a secured online messaging system. The therapists were instructed to try to dedicate a maximum of 10 minutes per week per patient to e-mail communication. Intervention lasted 10 weeks.

Intervention 2 (n=43):

Group Cognitive Behavioural Therapy (GCBT). The group sizes included 5 to 12 participants and the topics included sharing experiences, discussing individual coping strategies, and demonstrating exercises. 90 minute weekly sessions for 10 weeks.

Comparison (n=44):

Web-based discussion forum (DF) as a control condition. A new discussion topic was presented every week. The participants were encouraged to discuss and to comment on each other’s postings. The topics did not include any strategies to improve tinnitus distress but instead focused on individual experiences and attitudes concerning tinnitus.

n=128

People presenting with tinnitus at least mild levels of chronic tinnitus distress for at least 6 months

Age (mean): iCBT 51.3(9.8); GCBT 50.2 (13.1); DF 52.1 (9)

Gender (male to female ratio): ICBT 25/16; GCBT 24/199; DF 28/16

Duration of tinnitus (mean): iCBT 9.2 years, GCBT 8.4years; DF 8 years

Germany

Tinnitus distress(follow-up : post-treatment): measured using miniTQ, total score range from 0-24

Tinnitus severity (follow-up: post-treatment): measured using THI, total score range 0-100.

Depression (follow-up: post treatment): measured using HADS – Depression, total score range 0-21

Anxiety (follow-up: post-treatment measured using HADS- Anxiety, total score range 0-21

Sleep (follow-up: post treatment): measured using ISI total score range 0-28

Kreuzer 2012³¹

RCT

Intervention (n=18):

Mindfulness and body-psychotherapy-based group treatment - treatment program consisted of mindfulness, meditation, self-massage, and breathing exercises as main components by an experienced therapist. Two weekends (11 hours of treatment/weekend) with an interval of 7 weeks. A review was made at 2 weeks after each weekend and 11 and 15 weeks after the second training weekend of 2 hours each.

Comparison (n=18):

Waiting list control, assessed at identical time points during a waiting period of 24 weeks before they received treatment.

n=36

People presenting with chronic tinnitus for at least 6 months, participants were ‘burdened’ by their tinnitus

Age (mean): Intervention group: 49.6 years; control group: 51.7 years

Gender (male to female ratio): Intervention group: 1:1

Germany

Tinnitus annoyance (follow-up: post-treatment): measured using numeric rating scale, scale range not reported

Tinnitus severity (follow-up: post-treatment): measured using TQ, scale range 0-84.

Tinnitus severity (follow-up: post-treatment): measured using THI, scale range 0-100

Tinnitus loudness (follow-up: post-treatment): measured using numeric rating scale, scale range not reported

Depression (follow-up: post-treatment): measured using BDI, scale range 0-63

Kroner-Herwig 1995³⁴

RCT

Intervention (n=15):

Cognitive behavioural therapy (CBT) – sessions included a focus on cognition, education, analysis of stressful events and their effect on tinnitus progressive relaxation. The intervention consisted of ten 2-hour sessions, duration of intervention not reported.

Comparison (n=19):

Waiting-list control – following ‘experimental assessment’ participants were randomised to CBT or another intervention (yoga – not relevant for this evidence review) no further details reported.

n=34

People presenting with chronic idiopathic tinnitus for at least 6 months

Age (mean): 47.2 years

Gender (male to female ratio): 1.3:1

Duration of tinnitus (mean): 46.4 months

Germany

Tinnitus annoyance (follow-up: post-treatment): measured using visual analogue scales, scale range 0-10

Tinnitus loudness (follow-up: post-treatment): measured using visual analogue scales, scale range 0-10

Sleep disturbance (follow-up: post-treatment): measured using visual analogue scales, scale range 0-10

Kroner-Herwig 2003³³

RCT

Intervention 1 (n=56):

Cognitive behavioural therapy (CBT). An outpatient cognitive-behavioural group tinnitus coping training (TCT). 11 sessions of 90-120 minutes duration. 6 to 8 patients participated in each of 7 groups was conducted. A training manual gave detailed guidelines for training delivery. Topics included education on tinnitus aetiology and maintenance; relaxation; thoughts, emotions and bodily reactions; tinnitus as a stressor; dysfunctional and functional thoughts; attention and distraction; imagery exercises; habituation exercises, withdrawal and avoidance (cognitions and behaviour); problem solving (a systematic approach); attitudes toward illness and health.

Intervention 2 (n=20):

Minimal contact intervention (MC-E) involved 2 group sessions, the first involved education regarding tinnitus aetiology; fears regarding tinnitus, its prognosis and consequences were discussed and, if possible, revised. Self-help strategies for coping with tinnitus (e.g., distraction, relaxed confrontation, reappraisal) A second session in which subjects were given the opportunity to discuss their progress and problems followed after a 4-week period of implementing the recommended “self-help exercises”.

Intervention 3 (n=20):

MC-R group also received an educational session, where the importance of relaxation and distraction as strategies for coping with tinnitus was underlined. A second session involved audiocassettes with verbal relaxation instructions and pieces of relaxing music (30 min) selected by a music therapist. Patients were given the audiocassettes for home use and were instructed to choose the pieces of music, which suited them best. Two further meetings were used to discuss problems and progress.

Comparison (n=20):

Waiting list control (not further details reported).

n=116

People presenting with idiopathic tinnitus for at least 6 months

Age (mean): 46.8 years

Gender (male to female ratio): 1:1

Duration of tinnitus (mean): 5.5 years

Germany

Tinnitus distress (follow-up: post-treatment): measured using TQ, scale range 0-84

Tinnitus severity (follow-up: post-treatment): measured using GSI of SCL-90R, scale range not reported

Tinnitus loudness (follow-up: post-treatment): measured using diary, scale range 1-7

Depression (follow-up: post-treatment): measured using ADS, scale range 0-60

Li 2019 ³⁵

RCT

Intervention (n=50):

Cognitive behavioural therapy (CBT) - Intervention group received intervention twice a week. The treatment paths included three steps including cognitive restructuring, problem solving and sound treatment. Sound treatment involved hearing tests and tinnitus tests; masking treatment was applied using light music. Masking was performed for 30 minutes once a day. CBT intervention was twice a week for 6 months.

Comparison (n=50):

Control group received the same masking intervention as the intervention group.

n=100

People present with chronic subjective tinnitus for at least 3 months, participants had a negative mental mood such as fidgety and irritability

Age (mean): 43.22 years

Gender (male to female ratio): 1.4:1

Duration of tinnitus (mean): 2.52 years

China

Tinnitus severity (follow-up: post-treatment): measured using the Tinnitus Handicap Inventory, scale range not reported (according to literature it is 0-100)

Depression (follow-up: post-treatment): measured using the Symptom Checklist-90 (SCL-90) subscale for depression (F4), scale range 1-5

Anxiety (follow-up: post-treatment): measured using the Symptom Checklist-90 (SCL-90) subscale for anxiety (F5), scale range 1-5

Malouff 2010³⁹

RCT

Intervention (n=84):

CBT self-help book – participants received a self-help book based on cognitive-behavioural principles, including educational information on tinnitus and attention control techniques. Book provides guidelines on specific exercises such as progressive muscle relaxation and personalised self-instructions. Participants were instructed to complete the book within 2 months. No further contact was made with participants until follow-up.

Comparison (n=78):

Waiting-list control – participants were given the CBT self-help book after 2 months. No further details reported.

n=162

People presenting with tinnitus

Age (mean): 57.6 years

Gender (male to female ratio): 1.3:1

Duration of tinnitus (mean): Not reported

Australia

Tinnitus distress (follow-up: post-treatment): measured using Tinnitus Reaction Questionnaire (TRQ), scale range not reported (according to literature it is 0-104)

McKenna 2017⁴⁶

RCT

Intervention (n=39):

Mindfulness-based cognitive therapy (MBCT) – intervention was delivered in line with a standardised manual. There was an emphasis on sound meditation and education around the cognitive model of tinnitus and the importance of attentional processes in tinnitus. Psycho-education component which focused on cognitive theory. There were eight 120-minute group sessions, delivered weekly over 8 consecutive weeks.

Comparison (n=36):

Relaxation training – relaxation intervention delivered in line with a standardised manual. Psycho-education component which focused on physiology of stress and tinnitus. There were eight 120-minute group sessions, delivered weekly over 8 consecutive weeks.

n=75

People presenting with chronic tinnitus with psychological distress for at least 6 months

Age (median): 50.0 years

Gender (male to female ratio): 1.2:1

Duration of tinnitus (median): 56 months

United Kingdom

Tinnitus severity (follow-up: post-treatment and 6 months): measured using the Tinnitus Questionnaire (TQ), scale range not reported (according to literature it is 0-84)

Tinnitus severity (follow-up: post-treatment and 6 months): measured using the Tinnitus Functional Index (TFI), scale range not reported (according to literature it is 0-100)

Tinnitus loudness (follow-up: post-treatment and 6 months): measured using visual analogue scale (VAS), scale range 0-100

Depression (follow-up: post-treatment and 6 months): measured using Hospital Anxiety and Depression Scale (HADS) (depression subscale used), scale range not reported (according to literature it is 0-21)

Anxiety (follow-up: post-treatment and 6 months): measured using Hospital Anxiety and Depression Scale (HADS) (anxiety subscale used), scale range not reported (according to literature it is 0-21)

Nyenhuis 2013⁵⁰

RCT

Intervention 1 (n=71):

Cognitive behavioural therapy (CBT) (group-based) - based on standardised manual, contents were presented over four two-hour meetings. All four sessions contained a progressive muscle relaxation exercise. Topics covered included: education about tinnitus, functional characteristics of the hearing system, treatment options, psychological aspects of tinnitus distress, coping by attention and distraction. Intervention lasted 3 months.

Intervention 2 (n=79):

Cognitive behavioural therapy (CBT) (internet-based) – participants received the CBT manual, contents were written as web pages and participants could download the progressive muscle relaxation instructions. Intervention lasted 3 months.

Intervention 3 (n=77):

Cognitive behavioural therapy (CBT) (bibliotherapy) – participants received the complete manual and a CD with instructions on progressive muscle relaxation. Intervention lasted 3 months.

Comparison (n=77):

Information only – participants were provided with an 11-page booklet that provided information on the morphological and functional characteristics of the auditory system, the potential triggers of tinnitus and medical treatment options. No further treatment was provided.

n=304

People presenting with idiopathic tinnitus for 2-26 weeks

Age (mean): 50.3 years

Gender (male to female ratio): 1.2:1

Duration of tinnitus (mean) : 3.2 months

Germany

Tinnitus distress (follow-up: post-treatment and 9 months): measured using the Tinnitus Questionnaire (TQ) [German version], scale range not reported (according to literature it is 0-84)

Depression (follow-up: post-treatment and 9 months): measured using Patient Health Questionnaire-Depression (PHQ-D), scale range not reported

Philippot 2012⁵²

RCT

Intervention (n=15):

6 weekly group sessions of Mindfulness training. A manual was constructed for each training condition. The training involved dealing with the adversity of tinnitus; focus on the theme that thoughts are not facts; the main exercise consisted of a 40 minutes sitting meditation with a sequential focus on breath, body, thoughts and the introduction of a difficult thought in the meditation; dealing with how to take care of oneself (relapse prevention) and evaluating the programme. The main exercise consisted in a 40-minute body scan.

Comparison (n=15):

6 sessions of 2 and 15 hours per week of relaxation training, of which a manual was involved. The manual followed the progressive relaxation training format, including breathing training, relaxation was divided into thirteen body parts in the second session, in the third session in to eight body parts, the fourth session into four body parts and the fifth session into two body parts. The sixth session focused on mini-relaxation and on maintenance of relaxation competence.

n=30

People presenting with tinnitus in the past 6 months with significant psychological distress and impairment in everyday activities resulting from tinnitus

Age (mean): 60 years

Gender (male to female ratio): 1.5:1

Duration of tinnitus: Not reported

Belgium

Depression (follow-up: post-treatment and 3 month follow-up): measured by BDI, total scale range 0-63

Anxiety (follow-up: post-treatment and 3 months): measured using the Spielberger State and Trait Anxiety Inventory, total scale range 20-80

Rief 2005⁵³

RCT

Intervention (n=23):

Biofeedback - treatment program consisting of 1 pre-assessment session, 7 treatment sessions, and a final session summarising the intervention strategies and conducting the post-assessment. All sessions lasted approximately 1 hour. The training was manual-guided and also included handouts (e.g., on the following topics: basic information on ear and the hearing system; information processes involved in tinnitus; the vicious circle of tinnitus annoyance, muscular reactivity, and selective attention; and aspects of tinnitus maintenance, modulating factors, coping strategies. Total of 8 weeks duration.

Comparison (n=20):

Waiting list control group who waited 8 weeks. For the same sessions as the intervention group.

n=48

People presenting with tinnitus for at least 6 months that participants described as ‘disturbing’

Age (mean): 46.8 years

Gender (male to female ratio): 1:1

Duration of tinnitus (mean): 6.4 years

Germany

Tinnitus distress (follow-up: post-treatment and 6 months): measured using TQ, scale range 0-84.

Quality of life (health life satisfaction) (follow-up: post-treatment and 6 months): measured using questions on life satisfaction (FLZ), scale range not reported

Tinnitus loudness (follow-up: post-treatment and 6 months): measured using tinnitus diary, scale range 0-10.

Scott 1985⁵⁵

RCT

Intervention (n=12):

Behavioural therapy - psychological treatment comprised relaxation training, training of self-control by distraction exercises with the aim of reducing the discomfort from tinnitus and the application of the method in situations associated with tinnitus. Intervention was delivered by ten one-hour sessions during a 2-3 week period.

Comparison (n=12):

Waiting list group. After 10 weeks the group received the same as the treatment group.

n=24

People presenting with some form of hearing impairment and tinnitus grade 2 or 3

Age (mean): Men 50.6 (36-62) years; women 54.2 (36-72) years

Gender (male to female ratio): 1:1.2

Duration of tinnitus: 9.4 years

Sweden

Tinnitus annoyance (retrospective) (follow-up: post-treatment): measured using a diary, scale range 0-10

Tinnitus loudness (retrospective) (follow-up: post-treatment): measured using a diary, scale range 0-10

Tinnitus loudness (direct): (follow-up: post-treatment): measured using a diary, scale range 0-10

Depression (retrospective): (follow-up: post-): measured using a diary, scale range 0-10

Weise 2008⁵⁹

RCT

Intervention (n=63):

Cognitive behavioural therapy: biofeedback-based behavioural intervention conducted by 4 trained therapists. Twelve 1 hour sessions given over 3 months. Each session included biofeedback as well as CBT elements and followed a structured manual. The biofeedback facilitated muscle relaxation and learning of control over physiological functions. Various tinnitus-specific CBT techniques found previously to be effective were included in the sessions.

Comparison (n=67):

Waiting list group who waited 3 months for the same sessions as the intervention group.

n=130

People presenting with tinnitus for at least 6 months, participants had serious or severe tinnitus annoyance

Age (mean): 51.2 years

Gender (male to female ratio): 1.3:1

Duration of tinnitus (mean): 6.4 years

Germany

Tinnitus distress (follow-up: post-treatment)measured by diary.

Tinnitus severity (follow-up: post treatment), measured by Tinnitus Questionnaire, scale range 0-84

Tinnitus severity (follow-up: post-treatment) measured by (Global Severity Index of the SCL-90-R), scale range not reported

Tinnitus loudness: follow-up post-treatment at 3 months, measured by diary, scale range 0-10

Depression (follow-up: post-treatment), measured by (Beck Depression Inventory), scale range 0-63

Sleep (follow-up: post-treatment) measured by diary of sleep disturbance, scale range 0-10

Weise 2016⁶⁰

RCT

Intervention (n=62):

Internet-based CBT self-help program, based on a well-established CBT self-help manual. 12 mandatory and 6 optional text modules. Mandatory modules covered strategies to reduce tinnitus-related distress (e.g., relaxation, exposure to tinnitus, or cognitive restructuring. Optional modules addressed problems potentially associated with tinnitus, such as sleep, hearing, or concentration problems. Module structure: theory and general information, exercises, worksheets and solutions for common problems. Participants downloaded text modules or spoken instructions; read the theoretical framework and conducted exercises in daily life. Once per week, patients could communicate with the therapist via a secured encrypted webpage. Therapists were instructed to spend a maximum of 10min/week per patient for e-mail correspondence. 10 weeks duration.

Comparison (n=62):

Control group - a confidential, moderated, online discussion forum. 10 weeks duration.

n=124

People presenting with tinnitus for at least 6 months

Age (mean): 47.66 years

Gender (male to female ratio): 1:1.5

Duration of tinnitus: 7.29 years

Sweden

Tinnitus distress and severity: follow-up: 10 weeks), measured by THI, total score ranges 0-100

Tinnitus distress and severity: follow-up: 10 weeks), measured by mini-TQ, total score ranges 0-20

Anxiety: follow-up: 10 weeks), measured by HADS – anxiety, total score ranges 0-21

Depression: follow-up: 10 weeks), measured by HADS-depression, total score ranges 0-21

Sleep: follow-up: 10 weeks), measured by ISI, total score ranges 0-28

Westin 2011⁶²

RCT

Intervention (n=22):

Psychological therapy: acceptance and commitment therapy (ACT) – participants completed the ACT treatment, with individual weekly sessions. Treatment involved mindfulness and acceptance training to promote goal-directed behaviour.

Comparison (n=22):

Waiting-list control – participants received letter stating that they were on the waiting list for treatment. Treatment started after 10 weeks.

n=44

People presenting with tinnitus for at least 6 months

Age (mean): 51.5 years

Gender (male to female ratio): 1:1

Duration of tinnitus: 6.9 years

Sweden

Tinnitus severity (follow-up: post-treatment): measured using the Tinnitus Handicap Inventory (THI), total score ranges from 0-100

Quality of life (follow-up: post-treatment): measured using the Quality of Life Inventory (QOLI), total score range not reported

Depression (follow-up: post-treatment): measured using the Hospital Anxiety and Depression Scale (HADS) (depression subscale), total score ranges from 0-21

Anxiety (follow-up: post-treatment): measured using the Hospital Anxiety and Depression Scale (HADS) (anxiety subscale), total score ranges from 0-21

Sleep (follow-up: post-treatment): measured using the Insomnia Severity Index (ISI), total score ranges from 0-28

Included in combination review

Zachriat 2004⁶⁴

RCT

Intervention (n=29):

Cognitive behavioural therapy (CBT) - the following interventions were included: educated on physiological and psychological factors playing a role in tinnitus; taught relaxation exercises and the use of attention distraction strategies. Administered in groups of 6-8 tinnitus patients. The intervention included 11 weekly sessions.

Comparison (n=23):

Education - a single treatment session in which patients were informed about the physiology and psychology of tinnitus.

n=52

People presenting with tinnitus for > 3 months

Age (mean): 49.95 years

Gender (male to female ratio): 1.8:1

Duration of tinnitus (mean): 79 months

Germany

Tinnitus distress (follow-up: 11 weeks/post-treatment): measuring using the Tinnitus Questionnaire (TQ), score ranges from 0-84

Tinnitus loudness (follow-up: 11 weeks/post-treatment): measured using tinnitus perception diary and subjective change (scale range 1-7)

Included in combination review

Table 3Clinical evidence summary: CBT versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with CBT (95% CI)

Tinnitus severity

Global Severity Index (GSI of SCL-90R)

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

0.63

The mean tinnitus severity in the intervention groups was

0.09 lower

(0.31 lower to 0.13 higher)

Tinnitus distress

TQ/TRQ. Scale from: 0 to 84, 0-104.

103

(2 studies)

post-treatment

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

41.28

The mean tinnitus distress in the intervention groups was

0.74 standard deviations lower

(1.16 to 0.33 lower)

Tinnitus distress

TRQ. Scale from: 0 to 104.

(1 study)

3 months

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

32.5

The mean tinnitus distress in the intervention groups was

22.80 lower

(34.50 to 11.10 lower)

Tinnitus QoL

THQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus qol in the control groups was

60.88

The mean tinnitus qol in the intervention groups was

17.16 lower

(27.88 to 6.44 lower)

Tinnitus annoyance

VAS. Scale from: 0 to 4, 0-10.

(2 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance in the control groups was

3.04

The mean tinnitus annoyance in the intervention groups was

0.35 standard deviations lower

(0.84 lower to 0.14 higher)

Tinnitus loudness

VAS. Scale from: 0 to 4, 0-10.

129

(3 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

4.47

The mean tinnitus loudness in the intervention groups was

0.27 standard deviations lower

(0.64 lower to 0.09 higher)

Depression

HADS. Scale from: 0 to 21.

103

(2 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

13.78

The mean depression in the intervention groups was

0.21 standard deviations lower

(0.62 lower to 0.2 higher)

Depression

HADS. Scale from: 0 to 21.

(1 study)

3 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

6.4

The mean depression in the intervention groups was

3.20 lower

(6.58 lower to 0.18 higher)

Anxiety

HADS. Scale from: 0 to 21.

(1 study)

3 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

6.4

The mean anxiety in the intervention groups was

4 lower

(6.21 to 1.79 lower)

Anxiety

ASI

(1 study)

3 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean anxiety in the control groups was

26.3

The mean anxiety in the intervention groups was

14.7 lower

(21.54 to 7.86 lower)

Sleep disturbance

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep disturbance in the control groups was

The mean sleep disturbance in the intervention groups was

0.34 lower

(1.98 lower to 1.3 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 4Clinical evidence summary: CBT versus control (masking)

Outcomes

No of Participants Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Control (masking)

Risk difference with CBT (95% CI)

Tinnitus severity

THI. Scale from: 0 to 100.

100

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus severity in the control groups was

48.72

The mean tinnitus severity in the intervention groups was

12.94 lower

(16.32 to 9.56 lower)

Depression

Symptom Checklist-90. Scale from: 1 to 5.

100

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

2.42

The mean depression in the intervention groups was

0.3 lower

(0.56 to 0.04 lower)

Anxiety

Symptom Checklist-90. Scale from: 1 to 5.

100

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

2.73

The mean anxiety in the intervention groups was

0.78 lower

(0.99 to 0.57 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 5Clinical evidence summary: CBT versus information only

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Information only

Risk difference with CBT (95% CI)

Tinnitus distress

TQ. Scale from: 0 to 84.

105

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

27.4

The mean tinnitus distress in the intervention groups was

7.40 lower

(13.65 to 1.15 lower)

Tinnitus distress

Scale from: 0 to 84.

(1 study)

9 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

25.2

The mean tinnitus distress in the intervention groups was

6.8 lower

(13.09 to 0.51 lower)

Depression

PHQ-D

105

(2 studies)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean depression in the control groups was

5.7

The mean depression in the intervention groups was

1.00 lower

(2.85 lower to 0.85 higher)

Depression

PHQ-D

(1 study)

9 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

5.7

The mean depression in the intervention groups was

0.9 lower

(2.69 lower to 0.89 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 6Clinical evidence summary: CBT versus education

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Education

Risk difference with CBT (95% CI)

Tinnitus severity

Global Severity Index (GSI of SCL90R)

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

0.53

The mean tinnitus severity in the intervention groups was

0.01 higher

(0.23 lower to 0.25 higher)

Tinnitus distress

TRQ. Scale from: 0 to 84, 104.

146

(3 studies)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus distress in the control groups was

38.01

The mean tinnitus distress in the intervention groups was

0.40 standard deviations lower

(0.75 lower to 0.06 higher)

Tinnitus distress

TQ. Scale from: 0 to 104.

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

45.94

The mean tinnitus distress in the intervention groups was

1.88 lower

(16.69 lower to 12.93 higher)

Tinnitus QoL

THQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus qol in the control groups was

59.34

The mean tinnitus qol in the intervention groups was

15.62 lower

(26.51 to 4.73 lower)

Tinnitus QoL

THQ

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus qol in the control groups was

55.23

The mean tinnitus qol in the intervention groups was

2.76 lower

(14.69 lower to 9.17 higher)

Tinnitus loudness

VAS and subjective change. Scale from: 0 to 4.

(2 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

3.49

The mean tinnitus loudness in the intervention groups was

0.32 standard deviations lower

(0.74 lower to 0.11 higher)

Tinnitus loudness

Diary

106

(2 studies)

11 weeks - 6 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus loudness in the control groups was

4.11

The mean tinnitus loudness in the intervention groups was

0.06 lower

(0.78 lower to 0.67 higher)

Tinnitus annoyance

VAS. Scale from: 0 to 4.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance in the control groups was

2.77

The mean tinnitus annoyance in the intervention groups was

0.46 lower

(0.95 lower to 0.03 higher)

Tinnitus annoyance

VAS. Scale from: 0 to 4.

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance in the control groups was

2.88

The mean tinnitus annoyance in the intervention groups was

0.63 lower

(1.37 lower to 0.11 higher)

Depression

BDI. Scale from: 0 to 63.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW²

due to risk of bias, imprecision

The mean depression in the control groups was

11.45

The mean depression in the intervention groups was

0.45 higher

(4.39 lower to 5.29 higher)

Depression

BDI/ADS. Scale from: 0 to 63, 0-60.

(2 studies)

6-12 months

⊕⊝⊝⊝

VERY LOW²

due to risk of bias, imprecision

The mean depression in the control groups was

12.44

The mean depression in the intervention groups was

0.06 standard deviations lower

(0.5 lower to 0.38 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 7Clinical evidence summary: CBT versus relaxation

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Relaxation

Risk difference with CBT (95% CI)

Tinnitus severity

Global Severity Index (GSI iof SCL-90R)

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

0.75

The mean tinnitus severity in the intervention groups was

0.21 lower

(0.55 lower to 0.13 higher)

Tinnitus distress

TQ. Scale from: 0 to 84.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean distress in the control groups was

31.27

The mean tinnitus distress in the intervention groups was

7.6 lower

(13.95 to 1.25 lower)

Tinnitus loudness

Diary. Scale from: 1 to 7.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean loudness (diary) (post treatment 6 months) in the control groups was

3.88

The mean tinnitus loudness in the intervention groups was

0.04 lower

(0.93 lower to 0.85 higher)

Depression

ADS

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

18.33

The mean depression in the intervention groups was

5.93 lower

(12.11 lower to 0.25 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 8Clinical evidence summary: CBT versus passive relaxation training

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Passive relaxation training

Risk difference with CBT (95% CI)

Tinnitus distress

TEQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

The mean tinnitus distress in the intervention groups was

0.3 higher

(2.2 lower to 2.8 higher)

Tinnitus distress

TEQ

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

15.5

The mean tinnitus distress in the intervention groups was

0.2 lower

(2.33 lower to 1.93 higher)

Tinnitus loudness

Tinnitus loudness rating.

Scale from: 1 to 5.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

The mean tinnitus loudness in the intervention groups was

0 higher

(0.72 lower to 0.72 higher)

Tinnitus loudness

Tinnitus loudness rating.

Scale from: 1 to 5.

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

The mean tinnitus loudness in the intervention groups was

0.03 lower

(0.54 lower to 0.48 higher)

Tinnitus annoyance (most annoying)

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance (most annoying) in the control groups was

2.85

The mean tinnitus annoyance (most annoying) in the intervention groups was

0.75 higher

(0.1 to 1.4 higher)

Tinnitus annoyance (most annoying)

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance (most annoying) in the control groups was

The mean tinnitus annoyance (most annoying) in the intervention groups was

0 higher

(0.71 lower to 0.71 higher)

Depression

BDI. Scale from: 0 to 63.

(1 study)

1 month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

11.16

The mean depression in the intervention groups was

3.36 lower

(13.24 lower to 6.52 higher)

Anxiety

STAI- state. Scale from: 20 to 80.

(1 study)

1 month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

45.66

The mean anxiety in the intervention groups was

6.46 lower

(21.31 lower to 8.39 higher)

Anxiety

STAI-trait. Scale from: 20 to 80.

(1 study)

1 month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

52.16

The mean anxiety in the intervention groups was

7.06 lower

(18.48 lower to 4.36 higher)

Insomnia

TEQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean insomnia in the control groups was

8.57

The mean insomnia in the intervention groups was

0.03 higher

(2.09 lower to 2.15 higher)

Insomnia

TEQ

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was 9.33

The mean insomnia in the intervention groups was

0.13 lower

(2.05 lower to 1.79 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 9Clinical evidence summary: CBT versus applied relaxation training

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Applied relaxation training

Risk difference with CBT (95% CI)

Tinnitus distress

TEQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

The mean tinnitus distress in the intervention groups was

0.7 lower

(2.64 lower to 1.24 higher)

Tinnitus distress

TEQ

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

14.45

The mean tinnitus distress in the intervention groups was

0.85 higher

(1.07 lower to 2.77 higher)

Tinnitus loudness

Tinnitus loudness rating.

Scale from: 1 to 5.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

3.66

The mean tinnitus loudness in the intervention groups was

0.34 higher

(0.35 lower to 1.03 higher)

Tinnitus loudness

Tinnitus loudness rating.

Scale from: 1 to 5.

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

The mean tinnitus loudness in the intervention groups was

0.3 higher

(0.24 lower to 0.84 higher)

Tinnitus annoyance (most annoying)

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance (most annoying) in the control groups was

3.08

The mean tinnitus annoyance (most annoying) in the intervention groups was

0.52 higher

(0.13 lower to 1.17 higher)

Tinnitus annoyance (most annoying)

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance (most annoying) in the control groups was

3.18

The mean tinnitus annoyance (most annoying) in the intervention groups was

0.82 higher

(0 to 1.64 higher)

Depression

BDI. Scale from: 0 to 63.

(1 study)

1month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

6.83

The mean depression in the intervention groups was

0.97 higher

(4.09 lower to 6.03 higher)

Anxiety

STAI-state. Scale from: 20 to 80.

(1 study)

1 month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

40.41

The mean anxiety in the intervention groups was

1.21 lower

(12.12 lower to 9.7 higher)

Anxiety

STAI-trait. Scale from: 20 to 80.

(1 study)

1 month

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

44.33

The mean anxiety in the intervention groups was

0.77 higher

(6.78 lower to 8.32 higher)

Insomnia

TEQ

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean insomnia in the control groups was

8.58

The mean insomnia in the intervention groups was

0.02 higher

(1.75 lower to 1.79 higher)

Insomnia

TEQ

(1 study)

4 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean insomnia in the control groups was

9.09

The mean insomnia in the intervention groups was

0.11 higher

(0.93 lower to 1.15 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 10Clinical evidence summary: CBT-stepped intervention versus usual care

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Usual care

Risk difference with CBTstepped intervention (95% CI)

Tinnitus severity

TQ. Scale from: 0 to 84.

394

(1 study)

post-treatment

(step 1)

⊕⊕⊕⊕

HIGH

The mean tinnitus severity in the control groups was

45.51

The mean tinnitus severity in the intervention groups was

3.5 lower

(7.4 lower to 0.4 higher)

Tinnitus severity

TQ. Scale from: 0 to 84.

332

(1 study)

12 months

(step 2)

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus severity in the control groups was

42.12

The mean tinnitus severity in the intervention groups was

8.69 lower

(12.66 to 4.72 lower)

Quality of life

HUI. Scale from: -0.36 to 1.

394

(1 study)

post-treatment

(step 1)

⊕⊕⊕⊝

MODERATE²

due to imprecision

The mean quality of life in the control groups was

0.64

The mean quality of life in the intervention groups was

0.02 lower

(0.08 lower to 0.04 higher)

Quality of life

HUI. Scale from: -0.36 to 1.

342

(1 study)

12 months

(step 2)

⊕⊕⊕⊝

MODERATE²

due to risk of bias

The mean quality of life in the control groups was

0.63

The mean quality of life in the intervention groups was

0.05 higher

(0.01 to 0.11 higher)

Tinnitus-related quality of life

THI. Scale from: 0 to 100.

394

(1 study)

post-treatment

(step 1)

⊕⊕⊕⊕

HIGH

The mean tinnitus-related quality of life in the control groups was

37.38

The mean tinnitus-related quality of life in the intervention groups was

3.13 lower

(7.79 lower to 1.53 higher)

Tinnitus-related quality of life

THI. Scale from: 0 to 100.

332

(1 study)

12 months

(step 2)

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus-related quality of life in the control groups was

33.51

The mean tinnitus-related quality of life in the intervention groups was

7.06 lower

(11.63 to 2.49 lower)

Depression and anxiety

HADS. Scale from: 0 to 42.

394

(1 study)

post-treatment

(step 1)

⊕⊕⊕⊕

HIGH

The mean depression and anxiety in the control groups was

12.08

The mean depression and anxiety in the intervention groups was

0.17 lower

(1.82 lower to 1.48 higher)

Depression and anxiety

HADS. Scale from: 0 to 42.

332

(1 study)

12 months

(step 2)

⊕⊕⊕⊕

HIGH

The mean depression and anxiety in the control groups was

10.83

The mean depression and anxiety in the intervention groups was

0.61 lower

(2.24 lower to 1.02 higher)

1: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.
2: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias

Table 11Clinical evidence summary: CBT (self-help book) versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with CBT (book) (95% CI)

Tinnitus distress

TRQ. Scale from: 0 to 104.

125

(1 study)

3 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

20.67

The mean tinnitus distress in the intervention groups was

5.12 lower

(10.66 lower to 0.42 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 12Clinical evidence summary: CBT (bibliotherapy) versus information only

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Information only

Risk difference with CBTbibliotherapy (95% CI)

Tinnitus distress

TQ. Scale from: 0 to 84.

109

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus distress in the control groups was

27.4

The mean tinnitus distress in the intervention groups was

1.10 lower

(8.37 lower to 6.17 higher)

Tinnitus distress

TQ. Scale from: 0 to 84.

(1 study)

9 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

25.2

The mean tinnitus distress in the intervention groups was

4.40 lower

(11.64 lower to 2.84 higher)

Depression

PHQ-D. Scale from: 0 to 120.

109

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

5.7

The mean depression in the intervention groups was

0.70 higher

(1.34 lower to 2.74 higher)

Depression

PHQ-D. Scale from: 0 to 120.

(1 study)

9 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

5.7

The mean depression in the intervention groups was

0.80 higher

(1.29 lower to 2.89 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 13Clinical evidence summary: CBT versus control (web discussion forum)

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Control (web discussion forum)

Risk difference with CBT (95% CI)

Tinnitus distress

Mini-TQ. Scale from: 0 to 24.

(1 study)

10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean distress in the control groups was

11.09

The mean tinnitus distress in the intervention groups was

3 lower

(5.33 to 0.67 lower)

Tinnitus severity

THI. Scale from: 0 to 100.

(1 study)

10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean severity in the control groups was

37.46

The mean tinnitus severity in the intervention groups was

9.76 lower

(18.74 to 0.78 lower)

Depression

HADS. Scale from: 0 to 21.

(1 study)

10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

5.88

The mean depression in the intervention groups was

1.47 lower

(3.28 lower to 0.34 higher)

Anxiety

HADS. Scale from: 0 to 21.

(1 study)

10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

7.67

The mean anxiety in the intervention groups was

1.83 lower

(3.68 lower to 0.02 higher)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

10.91

The mean sleep in the intervention groups was

1.88 lower

(4.92 lower to 1.16 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 14Clinical evidence summary: iCBT versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with iCBT (95% CI)

Tinnitus annoyance

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance in the control groups was

5.8

The mean tinnitus annoyance in the intervention groups was

0.5 lower

(1.56 lower to 0.56 higher)

Tinnitus loudness

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

6.4

The mean tinnitus loudness in the intervention groups was

0.2 lower

(1.26 lower to 0.86 higher)

Depression

HADS - depression. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

The mean depression in the intervention groups was

0.8 lower

(2.76 lower to 1.16 higher)

Depression

HADS - depression. Scale from: 0 to 21.

(1 study)

1 year

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean depression in the control groups was

5.3

The mean depression in the intervention groups was

0 higher

(1.56 lower to 1.56 higher)

Anxiety

HADS - anxiety. Scale from: 0 to 21.

(1 study)

post-treatment

weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

6.8

The mean anxiety in the intervention groups was

0.9 lower

(2.88 lower to 1.08 higher)

Anxiety

HADS - anxiety. Scale from: 0 to 21.

(1 study)

1 year

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean anxiety in the control groups was

6.4

The mean anxiety in the intervention groups was

0.3 lower

(2.02 lower to 1.42 higher)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean sleep in the control groups was

6.7

The mean sleep in the intervention groups was

0.60 lower

(0.47 lower to 1.67 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 15Clinical evidence summary: iCBT versus information only

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Information only

Risk difference with iCBT (95% CI)

Tinnitus distress

TQ/TRQ. Scale from: 0 to 84, 0-104.

161

(2 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, inconsistency, imprecision

The mean tinnitus distress in the control groups was

20.68

The mean tinnitus distress in the intervention groups was

0.34 standard deviations lower

(0.66 to 0.03 lower)

Tinnitus distress

TQ. Scale from: 0 to 84.

(1 study)

9 months

⊕⊝⊝⊝

VERY LOW¹^,³

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

25.2

The mean tinnitus distress in the intervention groups was

5.8 lower

(12.71 lower to 1.11 higher)

Tinnitus annoyance

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,³

due to risk of bias, imprecision

The mean tinnitus annoyance in the control groups was

3.61

The mean tinnitus annoyance in the intervention groups was

0.23 lower

(1.1 lower to 0.64 higher)

Tinnitus loudness

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,³

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

4.48

The mean tinnitus loudness in the intervention groups was

0.1 higher

(0.84 lower to 1.04 higher)

Depression

DASS/PHQ-D. Scale from: not reported, 0-120.

161

(2 studies)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, inconsistency, imprecision

The mean depression in the control groups was

4.07

The mean depression in the intervention groups was

0.05 standard deviations higher

(0.26 lower to 0.36 higher)

Depression

PHQ-D

(1 study)

9 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean depression in the control groups was

5.7

The mean depression in the intervention groups was

0.2 higher

(1.92 lower to 2.32 higher)

Anxiety

DASS. Scale from: 0 to 120.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,³

due to risk of bias, imprecision

The mean anxiety in the control groups was

3.09

The mean anxiety in the intervention groups was

0.7 higher

(1.46 lower to 2.86 higher)

Sleep quality

VAS. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,³

due to risk of bias, imprecision

The mean sleep quality in the control groups was

4.17

The mean sleep quality in the intervention groups was

0.1 lower

(1.24 lower to 1.04 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 or 2 increments because heterogeneity, I2= > 50%, p= > 0.04, unexplained by subgroup analysis.
3: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 16Clinical evidence summary: iCBT versus tinnitus information counselling

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Tinnitus information counselling

Risk difference with iCBT (95% CI)

Tinnitus severity

THI. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

28.74

The mean tinnitus severity in the intervention groups was

6.41 lower

(14.71 lower to 1.89 higher)

Tinnitus severity

THI. Scale from: 0 to 100.

(1 study)

2 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

27.11

The mean tinnitus severity in the intervention groups was

9.33 lower

(17.77 to 0.89 lower)

Tinnitus distress

TFI. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

34.88

The mean tinnitus distress in the intervention groups was

7 lower

(16.6 lower to 2.6 higher)

Tinnitus distress

TFI. Scale from: 0 to 100.

(1 study)

2 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

32.51

The mean tinnitus distress in the intervention groups was

9.66 lower

(19.4 lower to 0.08 higher)

Quality of life

SWLS. Scale from: 5 to 35.

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean quality of life in the control groups was

20.05

The mean quality of life in the intervention groups was

0.05 higher

(2.16 lower to 2.26 higher)

Quality of life

SWLS. Scale from: 5 to 35.

(1 study)

2 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

20.5

The mean quality of life in the intervention groups was

0.5 higher

(1.78 lower to 2.78 higher)

Depression

PHQ-9. Scale from: 0 to 27.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

4.19

The mean depression in the intervention groups was

0.52 lower

(2.14 lower to 1.1 higher)

Depression

PHQ-9. Scale from: 0 to 27.

(1 study)

2 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

4.97

The mean depression in the intervention groups was

2.19 lower

(3.95 to 0.43 lower)

Anxiety

GAD-7. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean anxiety in the control groups was

3.33

The mean anxiety in the intervention groups was

0.12 higher

(1.43 lower to 1.67 higher)

Anxiety

GAD-7. Scale from: 0 to 21.

(1 study)

2 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean anxiety in the control groups was

3.42

The mean anxiety in the intervention groups was

0.09 lower

(1.64 lower to 1.46 higher)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

9.55

The mean sleep in the intervention groups was

2.84 lower

(5.42 to 0.26 lower)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

2 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

10.03

The mean sleep in the intervention groups was

4.34 lower

(7.01 to 1.67 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 17Clinical evidence summary: iCBT versus control (web discussion forum)

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Control (web discussion forum)

Risk difference with iCBT (95% CI)

Tinnitus severity and distress

THI. Scale from: 0 to 100.

262

(3 studies)

8-10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity and distress in the control groups was

44.39

The mean tinnitus severity and distress in the intervention groups was

12.16 lower

(16.37 to 7.96 lower)

Tinnitus distress

Mini-TQ. Scale from: 0 to 20.

200

(2 studies)

8-10 weeks

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus distress in the control groups was

12.18

The mean tinnitus distress in the intervention groups was

4.42 lower

(5.74 to 3.1 lower)

Quality of life

QoLI

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

2.27

The mean quality of life in the intervention groups was

0.26 higher

(0.5 lower to 1.02 higher)

Depression

HADS. Scale from: 0 to 21.

262

(3 studies)

8-10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

6.44

The mean depression in the intervention groups was

1.95 lower

(2.89 to 1.02 lower)

Anxiety

HADS. Scale from: 0 to 21.

262

(3 studies)

8-10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

7.43

The mean anxiety in the intervention groups was

1.66 lower

(2.53 to 0.79 lower)

Sleep

ISI. Scale from: 0 to 28.

262

(3 studies)

8-10 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

11.23

The mean sleep in the intervention groups was

2.9 lower

(4.42 to 1.38 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 18Clinical evidence summary: iCBT versus iACT

Outcomes

No of Participants (studies) Follow up

Quality of the evidence

Relative effect (95 % CI)

Anticipated absolute effects

Risk with iACT

Risk difference with iCBT (95% CI)

Tinnitus distress and severity

THI. Scale from: 0 to 100.

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean distress and severity in the control groups was

31.94

The mean distress and severity in the intervention groups was

6.99 higher

(1.64 lower to 15.62 higher)

Tinnitus distress and severity

THI. Scale from: 0 to 100.

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean distress and severity in the control groups was

44.26

The mean distress and severity in the intervention groups was

3.79 lower

(14.76 lower to 7.18 higher)

Quality of life

QoLI

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

2.12

The mean quality of life in the intervention groups was

0.41 higher

(0.34 lower to 1.16 higher)

Quality of life

QoLI

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

1.84

The mean quality of life in the intervention groups was

0.64 higher

(0.11 lower to 1.39 higher)

Anxiety

HADS. Scale from: 0 to 21.

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

4.21

The mean anxiety in the intervention groups was

0.46 higher

(0.97 lower to 1.89 higher)

Anxiety

HADS. Scale from: 0 to 21.

(1 study)

12 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

6.39

The mean anxiety in the intervention groups was

1.49 lower

(3.48 lower to 0.5 higher)

Depression

HADS. Scale from: 0 to 21.

(1 study)

8 weeks

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean depression in the control groups was

3.48

The mean depression in the intervention groups was

0.11 lower

(1.54 lower to 1.32 higher)

Depression

HADS. Scale from: 0 to 21.

(1 study)

12 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean depression in the control groups was

5.03

The mean depression in the intervention groups was

1.96 lower

(3.55 to 0.37 lower)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

8 weeks

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean sleep in the control groups was

3.48

The mean sleep in the intervention groups was

1.45 higher

(1.62 lower to 4.52 higher)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

12 months

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean sleep in the control groups was

17.32

The mean sleep in the intervention groups was

5.29 lower

(9.88 to 0.70 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 19Clinical evidence summary: Biofeedback versus waiting list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with Biofeedback (95% CI)

Tinnitus distress

Tinnitus diary. Scale from: 0 to 84.

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

28.47

The mean tinnitus distress in the intervention groups was

1.33 lower

(9.77 lower to 7.11 higher)

Tinnitus distress

TQ. Scale from: 0 to 84.

(1 study)

6 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

28.11

The mean tinnitus distress in the intervention groups was

3.29 lower

(14.15 lower to 7.57 higher)

Quality of life

Health Life Satisfaction

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

62.68

The mean quality of life in the intervention groups was

0.54 higher

(20.48 lower to 21.56 higher)

Quality of life

Health Life Satisfaction

(1 study)

6 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

46.53

The mean quality of life in the intervention groups was

7.47 higher

(17.67 lower to 32.61 higher)

Tinnitus loudness

Tinnitus diary. Scale from: 0 to 10.

(1 study)

8 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

4.12

The mean tinnitus loudness in the intervention groups was

0.49 lower

(1.43 lower to 0.45 higher)

Tinnitus loudness

Tinnitus diary. Scale from: 0 to 10.

(1 study)

6 months

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

3.87

The mean tinnitus loudness in the intervention groups was

0.17 higher

(0.96 lower to 1.3 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 20Clinical evidence summary: Biofeedback-based CBT versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with Biofeedback-based CBT (95% CI)

Tinnitus severity

Global severity index of SLC-90-R

111

(1 study)

3 months

⊕⊕⊕⊝

MODERATE¹

due to risk of bias

The mean tinnitus severity in the control groups was

0.76

The mean tinnitus severity in the intervention groups was

0.01 lower

(0.21 lower to 0.19 higher)

Tinnitus distress

TQ. Scale from: 0 to 84.

111

(1 study)

3 months

⊕⊕⊕⊝

MODERATE¹

due to risk of bias

The mean tinnitus distress in the control groups was

49.54

The mean tinnitus distress in the intervention groups was

17.02 lower

(22.6 to 11.44 lower)

Tinnitus distress

Tinnitus diary

111

(1 study)

3 months

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus distress in the control groups was

5.22

The mean tinnitus distress in the intervention groups was

1.04 lower

(1.68 to 0.4 lower)

Tinnitus loudness

Tinnitus diary. Scale from: 0 to 10.

111

(1 study)

3 months

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

5.69

The mean tinnitus loudness in the intervention groups was

1.33 lower

(1.98 to 0.68 lower)

Depression

BDI. Scale from: 0 to 63.

111

(1 study)

3 months

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

13.38

The mean depression in the intervention groups was

1.09 lower

(4.16 lower to 1.98 higher)

Sleep

Sleep disturbance diary. Scale from: 0 to 10.

111

(1 study)

3 months

⊕⊕⊝⊝

LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

4.58

The mean sleep in the intervention groups was

1.37 lower

(2.28 to 0.46 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 21Clinical evidence summary: Behavioural therapy versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with Behavioural therapy (95% CI)

Tinnitus loudness (direct)

Diary. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness (direct) in the control groups was

7.21

The mean tinnitus loudness (direct) in the intervention groups was

0.96 lower

(2.49 lower to 0.57 higher)

Tinnitus loudness (retrospective)

Diary. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus loudness (retrospective) in the control groups was

The mean tinnitus loudness (retrospective) in the intervention groups was

1.01 lower

(2.80 lower to 0.78 higher)

Tinnitus annoyance (retrospective)

Diary. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus annoyance (retrospective) in the control groups was

2.73

The mean tinnitus annoyance (retrospective) in the intervention groups was

0.55 lower

(1.67 lower to 0.57 higher)

Depression (retrospective)

Diary. Scale from: 0 to 10.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression (retrospective) in the control groups was

2.84

The mean depression (retrospective) in the intervention groups was

0.92 lower

(1.93 lower to 0.09 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 22Clinical evidence summary: Mindfulness-based cognitive therapy versus relaxation

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Relaxation

Risk difference with Mindfulnessbased cognitive therapy (95% CI)

Tinnitus severity

TQ. Scale from: 0 to 84.

(1 study)

post-treatment

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus severity in the control groups was

38.2

The mean tinnitus severity in the intervention groups was

6.8 lower

(14.03 lower to 0.43 higher)

Tinnitus severity

TQ. Scale from: 0 to 84.

(1 study)

6 months

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus severity in the control groups was

35.6

The mean tinnitus severity in the intervention groups was

7.6 lower

(16.3 lower to 1.1 higher)

Tinnitus severity

TFI. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus severity in the control groups was

49.2

The mean tinnitus severity in the intervention groups was

7.00 lower

(16.09 to 2.09 lower)

Tinnitus severity

TFI. Scale from: 0 to 100.

(1 study)

6 months

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus severity in the control groups was

The mean tinnitus severity in the intervention groups was

11.80 lower

(23.06 to 0.54 lower)

Tinnitus loudness

VAS. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus loudness in the control groups was

59.2

The mean tinnitus loudness in the intervention groups was

2.6 lower

(13.94 lower to 8.74 higher)

Tinnitus loudness

VAS. Scale from: 0 to 100.

(1 study)

6 months

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean tinnitus loudness in the control groups was

65.4

The mean tinnitus loudness in the intervention groups was

10.3 lower

(23.79 lower to 3.19 higher)

Depression

HADS. Scale from: 0 to 21.

(2 studies)

post-treatment

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean depression in the control groups was

10.165

The mean depression in the intervention groups was

0.41 standard deviations lower

(0.82 lower to 0.01 higher)

Depression

HADS. Scale from: 0 to 21.

(2 studies)

6 months

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean depression in the control groups was

9.71

The mean depression in the intervention groups was

0.42 standard deviations lower

(0.85 lower to 0.01 higher)

Anxiety

HADS. Scale from: 0 to 21.

(2 studies)

post-treatment

⊕⊕⊕⊕

HIGH

The mean anxiety in the control groups was

27.925

The mean anxiety in the intervention groups was

0.24 standard deviations lower

(0.65 lower to 0.17 higher)

Anxiety

HADS. Scale from: 0 to 21.

(2 studies)

3-6 months

⊕⊕⊕⊝

MODERATE¹

due to imprecision

The mean anxiety in the control groups was

27.965

The mean anxiety in the intervention groups was

0.39 standard deviations lower

(0.82 lower to 0.03 higher)

1: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 23Clinical evidence summary: Mindfulness meditation versus relaxation therapy

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Relaxation therapy

Risk difference with Mindfulness meditation (95% CI)

Tinnitus severity

VAS. Scale from: 0 to 10.

(1 study)

15 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

4.41

The mean tinnitus severity in the intervention groups was

1.5 lower

(2.51 to 0.49 lower)

Tinnitus loudness

VAS. Scale from: 0 to 10.

(1 study)

15 weeks

⊕⊝⊝⊝

VERY LOW¹

due to risk of bias, imprecision

The mean tinnitus loudness in the control groups was

5.11

The mean tinnitus loudness in the intervention groups was

0.64 lower

(1.79 lower to 0.51 higher)

Anxiety

HADS - anxiety. Scale from: 0 to 21.

(1 study)

15 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

5.89

The mean anxiety in the intervention groups was

1.3 lower

(3.08 lower to 0.48 higher)

Depression

HADS - depression. Scale from: 0 to 21.

(1 study)

15 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

5.15

The mean depression in the intervention groups was

0.33 lower

(2.07 lower to 1.41 higher)

Depression and anxiety

HADS - total. Scale from: 0 to 42.

(1 study)

15 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression and anxiety in the control groups was

11.037

The mean depression and anxiety in the intervention groups was

1.63 lower

(4.94 lower to 1.69 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 24Clinical evidence summary: Mindfulness and body psychotherapy-based group treatment versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95% CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with Mindfulness and body-psychotherapy-based group treatment (95% CI)

Tinnitus severity

TQ. Scale from: 0 to 84.

(1 study)

24 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

33.1

The mean tinnitus severity in the intervention groups was

6.6 lower

(18.18 lower to 4.98 higher)

Tinnitus severity

THI. Scale from: 0 to 100

(1 study)

24 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean severity in the control groups was

41.3

The mean tinnitus severity in the intervention groups was

14 lower

(28.43 lower to 0.43 higher)

Tinnitus annoyance

VAS. Scale from: 0 to 10.

(1 study)

24 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean annoyance in the control groups was

7.2

The mean tinnitus annoyance in the intervention groups was

1.8 lower

(3.6 lower to 0 higher)

Tinnitus loudness

VAS. Scale from: 0 to 10.

(1 study)

24 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean loudness in the control groups was

The mean tinnitus loudness in the intervention groups was

1.9 lower

(3.67 to 0.13 lower)

Depression

BDI. Scale from: 0 to 63.

(1 study)

24 weeks

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

13.3

The mean depression in the intervention groups was

5.7 lower

(10.85 to 0.55 lower)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 25Clinical evidence summary: iACT versus control (web discussion forum)

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Control (web discussion forum)

Risk difference with iACT (95% CI)

Tinnitus severity and distress

THI. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊕⊝⊝

LOW¹

due to risk of bias

The mean tinnitus severity and distress in the control groups was

49.94

The mean tinnitus severity and distress in the intervention groups was

18 lower

(25.46 to 10.54 lower)

Quality of life

QoLI

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

2.27

The mean quality of life in the intervention groups was

0.15 lower

(0.87 lower to 0.57 higher)

Depression

HADS - depression. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹

due to risk of bias, imprecision

The mean depression in the control groups was

4.59

The mean depression in the intervention groups was

1.11 lower

(2. 52 lower to 0.3 higher)

Anxiety

HADS - anxiety. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean anxiety in the control groups was

6.78

The mean anxiety in the intervention groups was

2.57 lower

(4.15 to 0.99 lower)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

8.48

The mean sleep in the intervention groups was

2.74 lower

(5.78 lower to 0.3 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 26Clinical evidence summary: ACT versus waiting-list control

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Waiting-list control

Risk difference with ACT (95% CI)

Tinnitus severity

THI. Scale from: 0 to 100.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean tinnitus severity in the control groups was

48.29

The mean tinnitus severity in the intervention groups was

20.86 lower

(32.76 to 8.96 lower)

Quality of life

QoLI

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean quality of life in the control groups was

1.92

The mean quality of life in the intervention groups was

0.86 higher

(0.12 lower to 1.84 higher)

Depression

HADS- depression. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

6.2

The mean depression in the intervention groups was

3 lower

(5.59 to 0.41 lower)

Anxiety

HADS – anxiety. Scale from: 0 to 21.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean depression in the control groups was

7.2

The mean anxiety in the intervention groups was

3.6 lower

(6.27 to 0.93 lower)

Sleep

ISI. Scale from: 0 to 28.

(1 study)

post-treatment

⊕⊝⊝⊝

VERY LOW¹^,²

due to risk of bias, imprecision

The mean sleep in the control groups was

11.8

The mean sleep in the intervention groups was

2.55 lower

(5.9 lower to 0.8 higher)

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Table 27Health economic evidence profile: Specialised care versus usual care

Study

Applicability

Limitations

Other comments

Incremental cost

Incremental effects

Cost effectiveness

Uncertainty

Maes 2014³⁷

Netherlands

Partially Applicable^(a)

Potentially Serious Limitations^(b)

Within trial (RCT) cost-utility analysis, with a 1yr follow up and 32% drop out rate.

£102 ^(c)

0.02 QALYs ^(d)

£7001 per QALY gained

Probability specialised care is cost effective in the base case (£20K and 30K threshold): 60% and 68%

: Abbreviations: QALY: quality-adjusted life years; RCT: randomised controlled trial
(a): The analysis takes a reasonable approach however as the study is from a Dutch perspective and QALYs are derived using HUI3 the study has been judged as partially applicable.
(b): This economic analysis is based on a single trial, with a very high dropout rate. Therefore, this study has been judged to have potentially serious limitations.
(c): 2009 euros converted into GBP using the purchasing power parities⁵¹
(d): Utilities were derived using the Health Utilities Index Mark III

Table 28Description of psychological strategies and the staff requirement

Psychological therapy	Group Size	Frequency ^(a)	Number of clinical staff required^(b)	Source
Supervised digital CBT	1	8 sessions: 8 weekly individual 10.9 minute phone calls	1 band 7 clinical psychologist under the supervision of band 8a principal psychologist.	Beukes (2018) and Jasper (2014) and GC^(c)
Group CBT	8	7 sessions: 6 weekly 2 hour group sessions and a 1hr follow-up group session	2 band 7 clinical psychologists under the supervision of band 8a principal psychologist.	GC
Individual CBT	1	6 sessions: 6 weekly 1 hour individual sessions and a 1hr follow-up individual session	1 Band 7 psychologist under the supervision of band 8a principal psychologist.	GC
Group mindfulness based cognitive therapy	12	9 sessions: 8 weekly 2hr group sessions and a 1.5hr follow-up group session	2 band 7 clinical psychologists under the supervision of band 8a principal psychologist. This intervention could also be delivered by other clinical staff trained in mindfulness.	GC
Group acceptance and commitment therapy^(d)	14	10 sessions: 10 weekly 2hr sessions	2 band 7 clinical psychologists under the supervision of band 8a principal psychologist.	NHS Worcestershire

(a): All sessions include an additional initial 1 hour individual consultation as advised by the guideline committee
(b): Many studies were not based in a UK setting and sometimes involved the provision of services by students on postgraduate degrees. In the NHS the provision of services would be from appropriately trained practitioners, and therefore the band and specialty of staff required was determined by the GC based on their clinical experience rather than the literature.
(c): The estimates for staff contact time for the digital CBT intervention varied in studies. In this costing analysis, the average has been taken of the 13.7 minutes of clinician contact time reported in Jasper (2014)²⁶ and the 8 minutes contact time reported in a recent UK study.⁹
(d): The time required for acceptance base therapy (ACT) has been sourced by NHS Worcestershire who provide acceptance and commitment therapy – though these sessions were not exclusively for tinnitus.

Table 29Frequency of supervision

Psychological therapy ^(a)	Supervision sessions for whole intervention	Supervising staff	Total supervising time (hours)
Supervised digital CBT	2 sessions	8a psychologist	2
Group CBT	2 sessions	8a psychologist	2
Individual CBT	2 sessions	8a psychologist	2
Group mindfulness based cognitive therapy	2 sessions	8a psychologist	2
Group acceptance and commitment therapy	3 sessions	8a psychologist	3

(a): This was preferred over the supervision presented in the literature as many studies were not UK based and often involved students on postgraduate courses. In the NHS the provision of services would be from appropriately trained practitioners who are supervised. The assumptions for the number of supervision sessions were therefore determined by the GC based on their clinical experience. The GC based their assumption on the number of supervision sessions required according to the duration of the intervention and the number of participants involved.

Table 30UK costs of clinical psychologists

Staff member ^(a)	Band	Cost per hour of patient contact
Clinical Psychologist	7	£53
Principal Psychologist	8a	£63

: Source[s]: PSSRU (2018)
(a): The committee indicated that a band 7 clinical psychologist would be expected to deliver psychological therapies under the supervision of a band 8a principal psychologist. However, the committee explained that other trained practitioners could also deliver group mindfulness based cognitive therapies.

Table 31Cost per patient for different psychological therapies^(a)

Psychological Therapy	Therapy	Supervision	Total
Supervised digital CBT	£77	£29	£106
Group CBT	£172	£29	£201
Individual CBT	£371	£29	£400
Group mindfulness cognitive based therapy	£155	£19	£174
Group acceptance and commitment therapy	£151	£25	£176

(a): The costs have been calculated by calculating the total staff hours required per patient for each intervention and then multiplying by the relevant unit cost per hour for each specific staff sourced from the PSSRU.¹⁸

Table 32Number of patients that require an additional intervention from a hypothetical (n=1000) tinnitus population

Psychological therapy strategy	Number requiring the second intervention ^(a)	Source
Supervised digital CBT stepped to individual CBT	480	Beukes, (2018)
Supervised digital CBT stepped to individual or group CBT^(b)	480	Beukes, (2018)
Group CBT stepped to individual CBT	180	GC estimate
Individual CBT stepped to group CBT	100	GC estimate
Group mindfulness CBT based therapy stepped to individual CBT	50	GC estimate
Group acceptance and commitment therapy stepped to individual CBT	250	GC estimate

(a): Estimates of the proportion of people with tinnitus that would require a second-line intervention. These estimates were sourced from the committee’s experience of current practice and a study by Beukes (2018)¹¹ Sensitivity analysis has been completed to consider alternative estimates.
(b): For this strategy it was assumed that half of those requiring a second intervention would have individual CBT and the other half would have group CBT.

Table 33Mean cost of different psychological therapy strategies and QALY gained required for the strategy to be cost effective compared to no intervention

Strategy	1^st line	2nd line^(a)	Both lines	QALYs required at the £20k threshold
Group mindfulness based cognitive therapy stepped up to individual CBT	£174	£20	£194	0.010
Supervised digital CBT stepped up to individual or group CBT	£106	£144	£250	0.013
Group CBT stepped up to individual CBT	£201	£72	£273	0.014
Group acceptance based therapy stepped up to individual CBT	£176	£100	£276	0.014
Supervised digital CBT stepped up to individual CBT	£106	£192	£298	0.015
Individual CBT alone	£400	£0	£400	0.020
Individual CBT stepped up to group CBT	£400	£20	£420	0.021
Sensitivity analysis
Supervised digital CBT stepped up to individual CBT (only 25% require second-line)	£106	£100	£206	0.010
Supervised digital CBT stepped up to individual or group CBT (only 25% require second-line)	£106	£75	£181	0.009

(a): Not all patients will require a second line intervention so only a proportion will be stepped up – see Table 32 for more details.

Table 34QALY gains achieved by adults with chronic pain after receiving psychological interventions

Intervention	QALY gains
Digital CBT	0.014
Group CBT	0.010
Group acceptance and commitment therapy	0.020

(a): Frisen (2017)²⁰
(b): Alda (2011) ²
(c): Luciano (2014) ³⁶

Final

Intervention evidence review

This evidence review was developed by the National Guideline Centre

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

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