PTSD
Conditions
Brief summary
In low and middle-income countries, access to state-of-the-art mental health care is often limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The investigators will execute a hybrid effectiveness-implementation randomized controlled trial (RCT) of ITH versus delayed ITH to evaluate mental health effectiveness and ease of implementation.
Detailed description
Background: Somalia has long been in a state of humanitarian crisis; trauma-related mental health needs are extremely high. Access to state-of-the-art mental health care is limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The 6-session intervention combines Islamic principles with empirically-supported exposure and cognitive restructuring principles for posttraumatic stress disorder (PTSD). ITH reduces training time, uses a train the trainers (TTT) model, and relies on local partnerships embedded within the strong communal mosque infrastructure. Methods: The investigators will conduct a hybrid effectiveness-implementation randomized control trial (RCT) in the Somaliland, with implementation in the cities of Hargeisa, Borama, and Burao. In this study, a lay-led, mosque-based intervention, Islamic Trauma Healing (ITH), to promote mental health and reconciliation will be examined in 200 participants, randomizing mosques to either immediate ITH or a delayed (waitlist; WL) ITH conditions. Participants will be assessed by assessors masked to condition at pre, 3 weeks, 6 weeks, and 3 month follow-up. Primary outcome will be assessor-rated posttraumatic stress symptoms (PTSD), with secondary outcomes of depression, somatic symptoms, and well-being. A TTT model will be tested, examining the implementation outcomes. Additional measures include potential mechanisms of change and economic evaluation. Conclusion: This trial has the potential to provide effectiveness and implementation data for an empirically-based principle trauma healing program for the larger Islamic community that may not seek mental health care or does not have access to such care.
Interventions
Manualized, lay-led psychosocial intervention
Sponsors
Study design
Eligibility
Inclusion criteria
* Experienced a DSM-5 Criterion A trauma at least 12 weeks ago * Report current re-experiencing or avoidance PTSD symptoms * Islamic faith * 18-70 years of age
Exclusion criteria
* Immediate suicide risk, with intent or plan * Cannot understand consent/visible cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5 | Change from pre to week 6 (immediate post intervention) | PTSD Severity, higher score worse severity, 0 to 80 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | Change from pre to week 6 (immediate post intervention) | Depression Severity, higher score worse severity, 0 to 27 |
| Somatic Symptoms Scale-8 | Change from pre to week 6 (immediate post intervention) | Somatic Symptom Severity, higher score worse severity, 0 to 32 |
| World Health Organization-5 Wellbeing Index | Change from pre to week 6 (immediate post intervention) | Quality of Well-Being, higher score better well-being, 0 to 25 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation Outcome Measure | Immediately post ITH intervention | Acceptability, appropriateness, and feasibility, higher better, 1 to 5 |
| Client Services Satisfaction Questionnaire | Immediately post ITH intervention | Satisfaction with ITH, high score higher satisfaction, 5 to 20 |
| Session Fidelity Checklist | ITH Session 1 through Session 6 | Session by session rating of adherence to the protocol, higher better, 0% to 100%, average items completed |
Countries
Somalia