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A Lay-Led Intervention for War and Refugee Related Trauma

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ClinicalTrials.gov Identifier: NCT03502278
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Seattle Pacific University
Case Western Reserve University
Information provided by (Responsible Party):
Lori Zoellner, University of Washington

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
PTSD Behavioral: Islamic Trauma Healing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Lay-Led Intervention for War and Refugee Related Trauma
Actual Study Start Date : July 14, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502278


Contacts
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Contact: Lori Zoellner, PhD 2066853126 zoellner@uw.edu
Contact: Ifrah Sheikh, MS 2066168863 iss10@uw.edu

Locations
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United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106-7123
Contact: Norah C Feeny, PhD    216-368-2695    ncf2@case.edu   
Principal Investigator: Norah C Feeny, PhD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Lori Zoellner, PhD    206-685-3617    zoellner@uw.edu   
Principal Investigator: Lori A Zoellner, PhD         
Principal Investigator: Jacob A Bentley, PhD         
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Seattle Pacific University
Case Western Reserve University
Investigators
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Principal Investigator: Lori A Zoellner, PhD University of Washington
  Study Documents (Full-Text)

Documents provided by Lori Zoellner, University of Washington:

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Responsible Party: Lori Zoellner, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03502278     History of Changes
Other Study ID Numbers: 49606
1R34MH112756 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the NIMH Data Archive
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Per requirements of the NIMH Archive.
Access Criteria: Per requirements of the NIMH Archive.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lori Zoellner, University of Washington:
refugee