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Completed

NCT Number: NCT03502278

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Islamic Trauma Healing

Behavioral

A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles

Primary outcomes

  1. PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015

    Time frame: 3 Month Follow-up

    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.

Secondary outcomes

  1. Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

    Time frame: 3 Month Follow-up

    The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.

  2. Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)

    Time frame: 3 Month Follow-up

    The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .

  3. Quality of well-being Index

    Time frame: 3 Month Follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Case Western Reserve University
  • National Institute of Mental Health (NIMH)
  • Seattle Pacific University

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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