A Scalable, Community-based Program for War and Refugee Trauma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Islamic Trauma Healing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Islamic Trauma Healing (ITH)<br>A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. | Behavioral: Islamic Trauma Healing<br>* Manualized, lay-led psychosocial intervention<br>|
| Other: Wait List/Delayed (ITH)<br>Six week waitlist condition and then crossed-over to six weeks of the ITH intervention | Behavioral: Islamic Trauma Healing<br>* Manualized, lay-led psychosocial intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5 | PTSD Severity, higher score worse severity, 0 to 80 | Change from pre to week 6 (immediate post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Depression Severity, higher score worse severity, 0 to 27 | Change from pre to week 6 (immediate post intervention) | 
| Somatic Symptoms Scale-8 | Somatic Symptom Severity, higher score worse severity, 0 to 32 | Change from pre to week 6 (immediate post intervention) | 
| World Health Organization-5 Wellbeing Index | Quality of Well-Being, higher score better well-being, 0 to 25 | Change from pre to week 6 (immediate post intervention) |