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

Not Applicable

Recruiting

• Conditions: PTSD
• Interventions: Behavioral: Islamic Trauma Healing

• Registration Number: NCT05890482
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2022-05-15
• Study First Submitted: 2023-02-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Immediate suicide risk, with intent or plan
• Cannot understand consent/visible cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait List/Delayed (ITH)	Islamic Trauma Healing	Six week waitlist condition and then crossed-over to six weeks of the ITH intervention
Islamic Trauma Healing (ITH)	Islamic Trauma Healing	A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Somatic Symptoms Scale-8	Change from pre to week 6 (immediate post intervention)	Somatic Symptom Severity, higher score worse severity, 0 to 32
Patient Health Questionnaire-9	Change from pre to week 6 (immediate post intervention)	Depression Severity, higher score worse severity, 0 to 27

Trial Locations

Locations (2)

University of Burao; 🇸🇴 Burao, Somalia

Somaliland Youth Development and Voluntary Organization; 🇸🇴 Burao, Somalia