Clinical trial NCT05890482: A Scalable, Community-based Program for War and Refugee Trauma
Official title: Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2023-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
timeFrame: Change from pre to week 6 (immediate post intervention)
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Change from pre to week 6 (immediate post intervention)
measure: Somatic Symptoms Scale-8
timeFrame: Change from pre to week 6 (immediate post intervention)
measure: World Health Organization-5 Wellbeing Index
timeFrame: Change from pre to week 6 (immediate post intervention)
Other outcomes:
measure: Session Fidelity Checklist
timeFrame: ITH Session 1 through Session 6
measure: Implementation Outcome Measure
timeFrame: Immediately post ITH intervention
measure: Client Services Satisfaction Questionnaire
timeFrame: Immediately post ITH intervention
Locations:
city: Burao
country: Somalia
facility: Somaliland Youth Development and Voluntary Organization
city: Burao
country: Somalia
facility: University of Burao
Study officials:
affiliation: Case Western Reserve University
name: Norah C Feeny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jacob A Bentley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Lori A Zoellner, PhD
role: PRINCIPAL_INVESTIGATOR
References: