Evidence reviews for psychological and psychosocial interventions for family members of people at risk of, or with, PTSD

• Psychological interventions
• Psychosocial interventions
• Other non-pharmacological interventions

• Any other intervention
• Prevention as usual
• Waitlist
• Placebo

• Family member/carer mental health
• Family member/carer wellbeing or quality of life
• Carer burden

• Employment
• Housing
• Lifestyle disruption
• Relationship difficulties

RQ. 5.1 For family members (including children and carers) of people at risk of PTSD, do specific psychological, psychosocial or other non-pharmacological interventions result in an improvement in their mental health and wellbeing, a reduction in burden and improved social and occupational outcomes?

RQ. 5.2 For family members (including children and carers) of people with clinically important post-traumatic stress symptoms, do specific psychological, psychosocial or other non-pharmacological interventions result in an improvement in their mental health and wellbeing, a reduction in burden and improved social and occupational outcomes?

Note: Formally there are two review question but they reflect 48 sub-questions if one were to structure them by intervention

Where evidence exists, consideration will be given to the specific needs of:-

women who have been exposed to sexual abuse or assault, or domestic violence

lesbian, gay, bisexual, transsexual or transgender people

people from black and minority ethnic groups

people who are homeless or in insecure accommodation

asylum seekers or refugees or other immigrants who are entitled to NHS treatment

people who have been trafficked

people who are socially isolated (and who are not captured by any other subgroup listed)

people with complex PTSD

people with neurodevelopmental disorders (including autism)

people with coexisting conditions (drug and alcohol misuse, common mental health disorders, eating disorders, personality disorders, acquired brain injury, physical disabilities and sensory impairments)

people who are critically ill or injured (for instance after a vehicle crash)

RQ 5.1:

Family members (including children and carers) of people at risk of PTSD

At risk of PTSD is defined (in accordance with DSM) as: Exposure to actual or threatened death, serious injury or sexual violation. The exposure must result from one or more of the following scenarios, in which the individual:

directly experiences the traumatic event;

witnesses the traumatic event in person;

learns that the traumatic event occurred to a close family member or close friend (with the actual or threatened death being either violent or accidental); or

experiences first-hand repeated or extreme exposure to aversive details of the traumatic event (not through media, pictures, television or movies unless work-related)

The at-risk population includes people with a diagnosis of acute stress disorder/acute stress reaction (according to DSM, ICD or similar criteria), people with clinically important PTSD symptoms within a month of the traumatic event, and people with sub-threshold symptoms

The at-risk population for this review will also include the following groups that may not be captured by the DSM criteria:

family members of people with PTSD

family members or carers of people with a life-threatening illness or injury

RQ 5.2:

Family members (including children and carers) of people with clinically important post-traumatic stress symptoms (as defined by a diagnosis of PTSD according to DSM, ICD or similar criteria, or clinically-significant PTSD symptoms as indicated by baseline scores above threshold on a validated scale)

If some, but not all, of a study’s participants are eligible for the review, where possible disaggregated data will be obtained. If this is not possible then the study will be included if at least 80% of its participants are eligible for this review.

Trials of people with adjustment disorders

Trials of people with traumatic grief

Trials of people with psychosis as a coexisting condition

Trials of people with learning disabilities

Trials of women with PTSD during pregnancy or in the first year following childbirth

Trials of adults in contact with the criminal justice system (not solely as a result of being a witness or victim)

Psychological interventions (psychological interventions listed below are examples of interventions which may be included either alone or in combination and delivered to the person with (or at risk of) PTSD and/or a parent or carer in an individual or group format):

Trauma-focused cognitive behavioural therapies (CBT), including cognitive therapy, cognitive processing therapy, compassion focused therapy, exposure therapy/prolonged exposure (PE), virtual reality exposure therapy (VRET), imagery rehearsal therapy, mindfulness-based cognitive therapy (MBCT), narrative exposure therapy (NET) and narrative exposure therapy for traumatized children and adolescents (KidNET)

Non-trauma-focused CBT, including stress inoculation training (SIT)

Psychologically-focused debriefing (including single session debriefing)

Eye movement desensitisation and reprocessing (EMDR)

Hypnotherapy

Psychodynamic therapies, including traumatic incident reduction (TIR)

Counselling, including non-directive/supportive/person-centred counselling

Human givens therapy

Combined somatic and cognitive therapies, including thought field therapy (TFT) and emotional freedom technique (EFT)

Coping skills training

Couple interventions, including cognitive-behavioural conjoint therapy

Parent training/family interventions, including behavioural family therapy (such as Child and Family Traumatic Stress Intervention [CFTSI])

Play therapy

Psychosocial interventions (psychosocial interventions listed below are examples of interventions which may be included either alone or in combination and delivered to the person with (or at risk of) PTSD and/or a parent or carer in an individual or group format):

Meditation

Mindfulness-based stress reduction (MBSR)

Nature-assisted therapies (including ecotherapy, horticultural therapy, therapeutic horticulture and nature-based therapy)

Supported employment (including individual placement and support [IPS] supported employment and Veterans Health Administration Vocational Rehabilitation Programme [VRP])

Psychoeducational interventions

Practical support (including financial and housing)

Peer support (including self-help groups and support groups)

Other non-pharmacological interventions (other non-pharmacological interventions listed below are examples of interventions which may be included either alone or in combination and delivered to the person with (or at risk of) PTSD and/or a parent or carer in an individual or group format):

Acupuncture (including classical acupuncture, electroacupuncture, auricular acupuncture, laser acupuncture and acupoint stimulation [such as acupressure, moxibustion and tapping])

Exercise (including anaerobic [such as heavy weight training, sprinting, high-intensity interval training] and aerobic [such as running/jogging, swimming, cycling and walking] exercise, both supervised and unsupervised)

Repetitive transcranial magnetic stimulation (rTMS)

Yoga (including all types of yoga)

Combination interventions, such as combined psychological plus pharmacological versus pharmacological alone, will also be considered here.

A distinction will be made between early interventions (delivered within 3 months of the traumatic event) and delayed interventions (delivered more than 3 months after the traumatic event)

Exclude:

Inoculation interventions for people who may be at risk of experiencing but have not experienced, a traumatic event

Any other intervention

Treatment as usual

Waitlist

Placebo

Family member/carer mental health (for instance: depression symptoms assessed with a validated scale including the Patient Health Questionnaire [PHQ-9], the Hospital Anxiety and Depression [HAD] Scale and the Beck Depression Inventory [BDI]; or general mental health assessed with a validated scale including the General Health Questionnaire long or short forms [GHQ-60; GHQ-30; GHQ-28; GHQ-12] and the Neuropsychiatry Inventory Caregiver Distress Scale)

Family member/carer wellbeing or quality of life (as assessed with a validated scale including the 36-item Short-Form Survey [SF-36], Health Status Questionnaire-12 and Warwick-Edinburgh Mental Well-being Scale [WEMWBS])

Carer burden (as assessed with a validated scale including the Caregiver Burden Interview, Carers Checklist, Family Burden Interview Schedule, Pearlin Caregiving Measures, Screen for Caregiver Burden, Social Behaviour Assessment Schedule, and Carers Assessment of Difficulties Index [CADI])

Employment (for instance, proportion of caregivers that stopped working in order to provide care)

Housing (for instance, number homeless or in insecure accommodation)

Lifestyle disruption (as assessed with a validated scale including the Activity Restriction Scale [ARS])

Relationship difficulties (with spouse and/or children, as assessed with a validated scale including the Inventory of Interpersonal Problems [IIP] and Self-Report Family Inventory [SFI])

Systematic reviews of RCTs

RCTs

Clinical trial registries (ISRCTN and ClinicalTrials​.gov) will be searched to identify any relevant unpublished trials and authors will be contacted to request study reports (where these are not available online). Unpublished data will only be included where a full study report is available with sufficient detail to properly assess the risk of bias. Authors of unpublished evidence will be asked for permission to use such data, and will be informed that summary data from the study and the study’s characteristics will be published in the full guideline

Conference abstracts and dissertations will not be included.

Primary, secondary, tertiary, social care and community settings.

Treatment provided to troops on operational deployment or exercise will not be covered.

Reviews

If existing systematic reviews are found, the GC will assess their quality, completeness, and applicability to the NHS and to the scope of the guideline. If the GC agrees that a systematic review appropriately addresses a review question, a search for studies published since the review will be conducted.

Data Extraction (selection and coding)

Citations from each search will be downloaded into EndNote and duplicates removed. Titles and abstracts of identified studies will be screened by two reviewers for inclusion against criteria, until a good inter-rater reliability has been observed (percentage agreement =>90% or Kappa statistics, K>0.60). Initially 10% of references will be double-screened. If inter-rater agreement is good then the remaining references will be screened by one reviewer. All primary-level studies included after the first scan of citations will be acquired in full and re-evaluated for eligibility at the time they are being entered into a study database (standardised template created in Microsoft Excel). At least 10% of data extraction will be double-coded. Discrepancies or difficulties with coding will be resolved through discussion between reviewers or the opinion of a third reviewer will be sought.

Non-English-language papers will be excluded (unless data can be obtained from an existing review).

Data Analysis

Where data is available, meta-analysis using a fixed-effects model will be used to combine results from similar studies. Heterogeneity will be considered and if a random-effects model is considered more appropriate it will be conducted.

For risk of bias, outcomes will be downgraded if the randomisation and/or allocation concealment methods are unclear or inadequate. Outcomes will also be downgraded if no attempts are made to blind the assessors or participants in some way, i.e. by either not knowing the aim of the study or the result from other tests. Outcomes will also be downgraded if there is considerable missing data (see below).

Handling missing data:

Where possible an intention to treat approach will be used outcomes will be downgraded if there is a dropout of more than 20%, or if there was a difference of >20% between the groups.

For heterogeneity: outcomes will be downgraded once if I2>50%, twice if I2 >80%

 For imprecision: outcomes will be downgraded if:

Step 1: If the 95% CI is imprecise i.e. crosses 0.8 or 1.25 (dichotomous) or −0.5 or 0.5 (for continuous). Outcomes will be downgraded one or two levels depending on how many lines it crosses.

Step 2: If the clinical decision threshold is not crossed, we will consider whether the criterion for Optimal Information Size is met, if not we will downgrade one level for the following.

for dichotomous outcomes: <300 events

for continuous outcomes: <400 participants

For clinical effectiveness, if studies report outcomes using the same scale mean differences will be considered, if not standardized mean differences (SMDs) will be considered and the following criteria will be used:

SMD <0.2 too small to likely show an effect

SMD 0.2 small effect

SMD 0.5 moderate effect

SMD 0.8 large effect

RR <0.8 or >1.25 clinical benefit

Anything less (RR >0.8 and <1.25), the absolute numbers will be looked at to make a decision on whether there may be a clinical effect.

Heterogeneity

(sensitivity analysis and subgroups)

Where substantial heterogeneity exists, sensitivity analyses will be considered, for instance:

Studies with <50% completion data (drop out of >50%) will be excluded.

Where possible, the influence of subgroups will be considered, including subgroup analyses giving specific consideration to the groups outlined in the sub-question section and to the following groups:

Trauma type (including single incident relative to chronic exposure)

Duration of intervention (for instance, short-term [≤12 weeks] relative to long-term [>12 weeks])

Intensity of intervention (for instance, low intensity [≤15 sessions] relative to high intensity [>15 sessions])First-line treatment relative to second-line treatment and treatment-resistant PTSD (≥2 inadequate treatments)

Acute PTSD symptoms (clinically important PTSD symptoms for less than 3 months) relative to chronic PTSD symptoms (clinically important PTSD symptoms for 3 months or more)