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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

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE July 14, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03502278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • 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.
  • 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) .
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Lay-Led Intervention for War and Refugee Related Trauma
Official Title  ICMJE A Lay-Led Intervention for War and Refugee Related Trauma
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE PTSD
Intervention  ICMJE Behavioral: Islamic Trauma Healing
A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles
Study Arms  ICMJE
  • Active Comparator: PTSD lay-led group treatment program
    This group will go through the Islamic Trauma Healing Program
    Intervention: Behavioral: Islamic Trauma Healing
  • No Intervention: Waitlist
    Waitlist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lori Zoellner, PhD 2066853126 zoellner@uw.edu
Contact: Ifrah Sheikh, MS 2066168863 iss10@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03502278
Other Study ID Numbers  ICMJE 49606
1R34MH112756 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be shared with the NIMH Data Archive
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Per requirements of the NIMH Archive.
Access Criteria: Per requirements of the NIMH Archive.
Responsible Party Lori Zoellner, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Seattle Pacific University
  • Case Western Reserve University
Investigators  ICMJE
Principal Investigator: Lori A Zoellner, PhD University of Washington
PRS Account University of Washington
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP