Cover of Evidence review for psychological therapies

Evidence review for psychological therapies

Tinnitus: assessment and management

Evidence review L

NICE Guideline, No. 155

Authors

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3711-0
Copyright © NICE 2020.

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.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

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

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of 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)
Table 3. Clinical evidence summary: CBT versus waiting-list control.

Table 3

Clinical evidence summary: CBT versus waiting-list control.

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

Table 4

Clinical evidence summary: CBT versus control (masking).

Table 5. Clinical evidence summary: CBT versus information only.

Table 5

Clinical evidence summary: CBT versus information only.

Table 6. Clinical evidence summary: CBT versus education.

Table 6

Clinical evidence summary: CBT versus education.

Table 7. Clinical evidence summary: CBT versus relaxation.

Table 7

Clinical evidence summary: CBT versus relaxation.

Table 8. Clinical evidence summary: CBT versus passive relaxation training.

Table 8

Clinical evidence summary: CBT versus passive relaxation training.

Table 9. Clinical evidence summary: CBT versus applied relaxation training.

Table 9

Clinical evidence summary: CBT versus applied relaxation training.

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

Table 10

Clinical evidence summary: CBT-stepped intervention versus usual care.

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

Table 11

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

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

Table 12

Clinical evidence summary: CBT (bibliotherapy) versus information only.

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

Table 13

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

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

Table 14

Clinical evidence summary: iCBT versus waiting-list control.

Table 15. Clinical evidence summary: iCBT versus information only.

Table 15

Clinical evidence summary: iCBT versus information only.

Table 16. Clinical evidence summary: iCBT versus tinnitus information counselling.

Table 16

Clinical evidence summary: iCBT versus tinnitus information counselling.

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

Table 17

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

Table 18. Clinical evidence summary: iCBT versus iACT.

Table 18

Clinical evidence summary: iCBT versus iACT.

Table 19. Clinical evidence summary: Biofeedback versus waiting list control.

Table 19

Clinical evidence summary: Biofeedback versus waiting list control.

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

Table 20

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

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

Table 21

Clinical evidence summary: Behavioural therapy versus waiting-list control.

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

Table 22

Clinical evidence summary: Mindfulness-based cognitive therapy versus relaxation.

Table 23. Clinical evidence summary: Mindfulness meditation versus relaxation therapy.

Table 23

Clinical evidence summary: Mindfulness meditation versus relaxation therapy.

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

Table 24

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

Acceptance and commitment therapy (ACT)
Table 25. Clinical evidence summary: iACT versus control (web discussion forum).

Table 25

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

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

Table 26

Clinical evidence summary: ACT versus waiting-list control.

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

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

Table 27

Health economic evidence profile: Specialised care versus usual care.

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.

Table 28. Description of psychological strategies and the staff requirement.

Table 28

Description of psychological strategies and the staff requirement.

Table 29. Frequency of supervision.

Table 29

Frequency of supervision.

Table 30. UK costs of clinical psychologists.

Table 30

UK costs of clinical psychologists.

Table 31. Cost per patient for different psychological therapies.

Table 31

Cost per patient for different psychological therapies.

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.

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

Table 32

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

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.

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

Table 33

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

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

Table 34

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

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.

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

Figure 1

Sensitivity analysis of mean cost per patient for each psychological therapy strategy. Diamonds indicate base case analysis estimates

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 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 37. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

CINAHL (EBSCO) search terms

PsycINFO (ProQuest) search terms

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 38. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

Download PDF (819K)

Appendix E. Forest plots

Cognitive behavioural therapy

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

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

Appendix F. GRADE tables

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

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

Table 41. Clinical evidence profile: CBT versus information only

Table 42. Clinical evidence profile: CBT versus education

Table 43. Clinical evidence profile: CBT versus relaxation

Table 44. Clinical evidence profile: CBT versus passive relaxation training

Table 45. Clinical evidence profile: CBT versus applied relaxation training

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

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

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

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

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

Table 51. Clinical evidence profile: iCBT versus information only

Table 52. Clinical evidence profile: iCBT versus tinnitus information counselling

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

Table 54. Clinical evidence profile: iCBT versus iACT

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

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

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

Appendix H. Health economic evidence tables

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Appendix I. Excluded studies

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

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

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