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

PTSD Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT05890482
• Study type: Interventional
• Source: University of Washington
• Contact: Lori A Zoellner, PhD
• Phone: 2066853126
• Email: zoellner@uw.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Completion date: December 31, 2024