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Clinical Trials/NCT05890482
NCT05890482
Recruiting
Not Applicable

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

University of Washington2 sites in 1 country200 target enrollmentMay 15, 2022
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
University of Washington
Enrollment
200
Locations
2
Primary Endpoint
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lori Zoellner

Professor: Psychology

University of Washington

Eligibility 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

Outcomes

Primary Outcomes

PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5

Time Frame: Change from pre to week 6 (immediate post intervention)

PTSD Severity, higher score worse severity, 0 to 80

Secondary Outcomes

  • World Health Organization-5 Wellbeing Index(Change from pre to week 6 (immediate post intervention))
  • Somatic Symptoms Scale-8(Change from pre to week 6 (immediate post intervention))
  • Patient Health Questionnaire-9(Change from pre to week 6 (immediate post intervention))

Study Sites (2)

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