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

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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Islamic Trauma Healing

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori A Zoellner, PhD; Phone Number: 2066853126; Email: zoellner@uw.edu
• Study Contact Backup: Name: Jacob A Bentley, PhD; Phone Number: 2067449534; Email: bentlj@uw.edu

Study Locations

• Somalia
  • Burao, Somalia
    • Recruiting
    • Somaliland Youth Development and Voluntary Organization
    • Contact: Mohamed H Aideed; Phone Number: 252634439674; Email: chairperson@soydavo.org
    • Contact: Abdisalan Awke; Phone Number: 252634439674; Email: director@soydavo.org
  • Burao, Somalia
    • Recruiting
    • University of Burao
    • Contact: Essa N Liban; Phone Number: 252634940888; Email: vc@uob-edu.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Islamic Trauma Healing (ITH); A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles.	Behavioral: Islamic Trauma Healing; Manualized, lay-led psychosocial intervention
Other: Wait List/Delayed (ITH); Six week waitlist condition and then crossed-over to six weeks of the ITH intervention	Behavioral: Islamic Trauma Healing; Manualized, lay-led psychosocial intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	Depression Severity, higher score worse severity, 0 to 27	Change from pre to week 6 (immediate post intervention)
Somatic Symptoms Scale-8	Somatic Symptom Severity, higher score worse severity, 0 to 32	Change from pre to week 6 (immediate post intervention)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Implementation Outcome Measure	Acceptability, appropriateness, and feasibility, higher better, 1 to 5	Immediately post ITH intervention
Client Services Satisfaction Questionnaire	Satisfaction with ITH, high score higher satisfaction, 5 to 20	Immediately post ITH intervention

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Case Western Reserve University
• Investigators: Principal Investigator: Norah C Feeny, PhD, Case Western Reserve University; Principal Investigator: Jacob A Bentley, PhD, University of Washington; Principal Investigator: Lori A Zoellner, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00015447; R2HC #70165 (Other Grant/Funding Number: Enhancing Learning & Research for Humanitarian Assistance)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to the data may be provided to qualified researchers engaging in independent scientific research on posttraumatic stress disorder. Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan and execution of a Data Sharing Agreement. Data shared will be coded, with no personal health information included.
• IPD Sharing Time Frame: Data request can be submitted starting 9 months after the article publication and data will be accessible for up to 24 months. Extensions will be considered on a case by case basis.

IPD Sharing Access Criteria

Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan, and execution of a Data Sharing Agreement.

For more information or to submit a request, please contact zoellner@uw.edu.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No