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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05890482
Acronym
ITH
Enrollment
200
Registered
2023-06-06
Start date
2022-05-15
Completion date
2024-12-31
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

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

Case Western Reserve University
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5Change from pre to week 6 (immediate post intervention)PTSD Severity, higher score worse severity, 0 to 80

Secondary

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

Other

MeasureTime frameDescription
Implementation Outcome MeasureImmediately post ITH interventionAcceptability, appropriateness, and feasibility, higher better, 1 to 5
Client Services Satisfaction QuestionnaireImmediately post ITH interventionSatisfaction with ITH, high score higher satisfaction, 5 to 20
Session Fidelity ChecklistITH Session 1 through Session 6Session by session rating of adherence to the protocol, higher better, 0% to 100%, average items completed

Countries

Somalia

Contacts

Primary ContactLori A Zoellner, PhD
zoellner@uw.edu2066853126
Backup ContactJacob A Bentley, PhD
bentlj@uw.edu2067449534

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026