A Lay-Led Intervention for War and Refugee Related Trauma

This study will examine the initial efficacy and feasibility of a program called Islamic Trauma Healing by conducting a small RCT (N = 60) comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a greater reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show a greater improvement in quality of well-being than those in the waitlist condition (WL).

Study Overview

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

Detailed Description

Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing mental wounds of trauma within mosques. The six-session intervention combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. A lay-led, group program promotes community building, acknowledges trauma's impact in the community, and facilitates wider implementation. The program is not referred to as "therapy" or "treatment" for "mental illness." It incorporates community building (e.g., shared tea, supplication), integrated Islamic principles that utilize cognitive restructuring through discussion of prophet narratives (e.g., faith during hard times, Prophet Job [Ayyub]), and exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately, the program will follow a self-sustaining train-the-trainer model, led by group leaders, empowering lay leaders to facilitate healing in their communities. Further, training time is dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group discussion leading rather than training as a lay therapist or mental health counselor. Preliminary data from a community sample and from initial men's and women's groups show a strong perceived need and match with the Islamic faith, with large effects obtained for pre- to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the intervention as operating on potential mechanisms of connectedness to the community, faith integration, healing, and growth. The preliminary data point to the program being well-received and offering a promising model for delivery of a trauma-focused intervention to Muslim communities. The next steps are examining Islamic Trauma Healing in a RCT, further isolating mechanisms of change, and ascertaining feasibility for wider dissemination studies.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Zoellner, PhD; Phone Number: 2066853126; Email: zoellner@uw.edu
• Study Contact Backup: Name: Ifrah Sheikh, MS; Phone Number: 2066168863; Email: iss10@uw.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-7123
      • Case Western Reserve University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Experienced a DSM-5 trauma at least 12 weeks ago
• Report current re-experiencing or avoidance symptoms
• Somali background
• Islamic faith
• 18-65 year 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PTSD lay-led group treatment program; This group will go through the Islamic Trauma Healing Program	Behavioral: Islamic Trauma Healing; A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles
No Intervention: Waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015	PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015). Twenty items comprise the PTSD severity scale, with scores ranging from 0 to 80 and higher scores indicating higher PTSD severity. A total score is calculated.	3 Month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.	3 Month Follow-up
Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)	The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .	3 Month Follow-up
Quality of well-being Index	The WHO-5 Wellbeing Index (WHO-5; Bech, Olsen, Kjoller, & Rasmussen, 2003) will be used to measure well-being. This five-item measure assesses emotional well-being on a 0-5 scale.	3 Month Follow-up

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Case Western Reserve University; Seattle Pacific University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2018
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: refugee
• Other Study ID Numbers: 49606; 1R34MH112756 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with the NIMH Data Archive
• IPD Sharing Time Frame: Per requirements of the NIMH Archive.
• IPD Sharing Access Criteria: Per requirements of the NIMH Archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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