ITH: A Scalable, Community-based Program for War and Refugee Trauma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Islamic Trauma Healing (ITH) A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. |
Behavioral: Islamic Trauma Healing
Manualized, lay-led psychosocial intervention
|
| Other: Wait List/Delayed (ITH) Six week waitlist condition and then crossed-over to six weeks of the ITH intervention |
Behavioral: Islamic Trauma Healing
Manualized, lay-led psychosocial intervention
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Somaliland Youth Development and Voluntary Organization | Burao | Somalia | ||
| 2 | University of Burao | Burao | Somalia |
Sponsors and Collaborators
- University of Washington
- Case Western Reserve University
Investigators
- Principal Investigator: Norah C Feeny, PhD, Case Western Reserve University
- Principal Investigator: Jacob A Bentley, PhD, University of Washington
- Principal Investigator: Lori A Zoellner, PhD, University of Washington
Study Documents (Full-Text)
More Information
Publications
None provided.- STUDY00015447
- R2HC #70165