A Lay-Led Intervention for War and Refugee Related Trauma

Sponsor
University of Washington (Other)
Overall Status
Unknown status
CT.gov ID
NCT03502278
Collaborator
National Institute of Mental Health (NIMH) (NIH), Seattle Pacific University (Other), Case Western Reserve University (Other)
60
2
2
32.6
30
0.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Islamic Trauma Healing
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist controlA small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Lay-Led Intervention for War and Refugee Related Trauma
Actual Study Start Date :
Jul 14, 2018
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

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

Waitlist

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Case Western Reserve University Cleveland Ohio United States 44106-7123
2 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Lori A Zoellner, PhD, University of Washington

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Lori Zoellner, Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT03502278
Other Study ID Numbers:
  • 49606
  • 1R34MH112756
First Posted:
Apr 18, 2018
Last Update Posted:
May 22, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lori Zoellner, Professor, University of Washington

Study Results

No Results Posted as of May 22, 2019