A Scalable, Community-based Program for War and Refugee Trauma
ITH
Islamic Trauma Healing: A Scalable, Community-based Program for War and Refugee Trauma
2 other identifiers
interventional
200
1 country
2
Brief Summary
In low and middle-income countries, access to state-of-the-art mental health care is often limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The investigators will execute a hybrid effectiveness-implementation randomized controlled trial (RCT) of ITH versus delayed ITH to evaluate mental health effectiveness and ease of implementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 6, 2023
May 1, 2023
2.6 years
February 20, 2023
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PTSD Scale - Interview for the Diagnostic and Statistical Manual Version 5
PTSD Severity, higher score worse severity, 0 to 80
Change from pre to week 6 (immediate post intervention)
Secondary Outcomes (3)
Patient Health Questionnaire-9
Change from pre to week 6 (immediate post intervention)
Somatic Symptoms Scale-8
Change from pre to week 6 (immediate post intervention)
World Health Organization-5 Wellbeing Index
Change from pre to week 6 (immediate post intervention)
Other Outcomes (3)
Session Fidelity Checklist
ITH Session 1 through Session 6
Implementation Outcome Measure
Immediately post ITH intervention
Client Services Satisfaction Questionnaire
Immediately post ITH intervention
Study Arms (2)
Islamic Trauma Healing (ITH)
EXPERIMENTALA lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles.
Wait List/Delayed (ITH)
OTHERSix week waitlist condition and then crossed-over to six weeks of the ITH intervention
Interventions
Manualized, lay-led psychosocial intervention
Eligibility Criteria
You may qualify if:
- Experienced a DSM-5 Criterion A trauma at least 12 weeks ago
- Report current re-experiencing or avoidance PTSD symptoms
- Islamic faith
- years of age
You may not qualify if:
- Immediate suicide risk, with intent or plan
- Cannot understand consent/visible cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Case Western Reserve Universitycollaborator
Study Sites (2)
Somaliland Youth Development and Voluntary Organization
Burao, Somalia
University of Burao
Burao, Somalia
Related Publications (1)
Zoellner LA, Feeny NC, Angula DA, Aideed MH, Liban EN, Egeh MH, Awke AI, Ismail AS, Kunle MA, Ali E, Levin CE, Burant CJ, Bentley JA. Islamic trauma healing (ITH): A scalable, community-based program for trauma: Cluster randomized control trial design and method. Contemp Clin Trials Commun. 2023 Dec 10;37:101237. doi: 10.1016/j.conctc.2023.101237. eCollection 2024 Feb.
PMID: 38222876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norah C Feeny, PhD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
Jacob A Bentley, PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Lori A Zoellner, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor: Psychology
Study Record Dates
First Submitted
February 20, 2023
First Posted
June 6, 2023
Study Start
May 15, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data request can be submitted starting 9 months after the article publication and data will be accessible for up to 24 months. Extensions will be considered on a case by case basis.
- Access Criteria
- Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan, and execution of a Data Sharing Agreement. For more information or to submit a request, please contact zoellner@uw.edu.
Access to the data may be provided to qualified researchers engaging in independent scientific research on posttraumatic stress disorder. Data will be provided to the requesting party following review and approval of a research proposal, statistical analysis plan and execution of a Data Sharing Agreement. Data shared will be coded, with no personal health information included.