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

PTSD Clinical Trial

— ITH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890482
• Other study ID #: STUDY00015447
• Secondary ID: R2HC #70165
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: Lori A Zoellner, PhD
• Phone: 2066853126
• Email: zoellner[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Islamic Trauma Healing
Manualized, lay-led psychosocial intervention

Locations

Country	Name	City	State
Somalia	Somaliland Youth Development and Voluntary Organization	Burao
Somalia	University of Burao	Burao

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Case Western Reserve University

Country where clinical trial is conducted

Somalia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Session Fidelity Checklist	Session by session rating of adherence to the protocol, higher better, 0% to 100%, average items completed	ITH Session 1 through Session 6
Other	Implementation Outcome Measure	Acceptability, appropriateness, and feasibility, higher better, 1 to 5	Immediately post ITH intervention
Other	Client Services Satisfaction Questionnaire	Satisfaction with ITH, high score higher satisfaction, 5 to 20	Immediately post ITH intervention
Primary	PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5	PTSD Severity, higher score worse severity, 0 to 80	Change from pre to week 6 (immediate post intervention)
Secondary	Patient Health Questionnaire-9	Depression Severity, higher score worse severity, 0 to 27	Change from pre to week 6 (immediate post intervention)
Secondary	Somatic Symptoms Scale-8	Somatic Symptom Severity, higher score worse severity, 0 to 32	Change from pre to week 6 (immediate post intervention)
Secondary	World Health Organization-5 Wellbeing Index	Quality of Well-Being, higher score better well-being, 0 to 25	Change from pre to week 6 (immediate post intervention)