A Lay-Led Intervention for War and Refugee Related Trauma

Study Overview
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Brief Summary
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This study will examine the initial efficacy and feasibility of a program called Islamic Trauma Healing by conducting a small RCT (N = 60) comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a greater reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show a greater improvement in quality of well-being than those in the waitlist condition (WL).

Detailed Description
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Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing mental wounds of trauma within mosques. The six-session intervention combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. A lay-led, group program promotes community building, acknowledges trauma's impact in the community, and facilitates wider implementation. The program is not referred to as therapy or treatment for mental illness. It incorporates community building (e.g., shared tea, supplication), integrated Islamic principles that utilize cognitive restructuring through discussion of prophet narratives (e.g., faith during hard times, Prophet Job [Ayyub]), and exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately, the program will follow a self-sustaining train-the-trainer model, led by group leaders, empowering lay leaders to facilitate healing in their communities. Further, training time is dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group discussion leading rather than training as a lay therapist or mental health counselor. Preliminary data from a community sample and from initial men's and women's groups show a strong perceived need and match with the Islamic faith, with large effects obtained for pre- to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the intervention as operating on potential mechanisms of connectedness to the community, faith integration, healing, and growth. The preliminary data point to the program being well-received and offering a promising model for delivery of a trauma-focused intervention to Muslim communities. The next steps are examining Islamic Trauma Healing in a RCT, further isolating mechanisms of change, and ascertaining feasibility for wider dissemination studies.

Official Title
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A Lay-Led Intervention for War and Refugee Related 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 trauma at least 12 weeks ago Report current re-experiencing or avoidance symptoms Somali background Islamic faith 18-65 year 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: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTSD lay-led group treatment program<br>This group will go through the Islamic Trauma Healing Program | Behavioral: Islamic Trauma Healing<br>* A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles<br>|
| No Intervention: Waitlist<br>Waitlist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015 | PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015). Twenty items comprise the PTSD severity scale, with scores ranging from 0 to 80 and higher scores indicating higher PTSD severity. A total score is calculated. | 3 Month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) | The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3. | 3 Month Follow-up | 
| Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002) | The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) . | 3 Month Follow-up | 
| Quality of well-being Index | The WHO-5 Wellbeing Index (WHO-5; Bech, Olsen, Kjoller, & Rasmussen, 2003) will be used to measure well-being. This five-item measure assesses emotional well-being on a 0-5 scale. | 3 Month Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refugee