- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761732
Islamic Trauma Healing: Feasibility Study
February 20, 2023 updated by: Lori Zoellner, University of Washington
This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life.
The hypothesis is that those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show improvement in quality of well-being.
Feasibility will also be examined by examining at retention, satisfaction, and community feedback.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 low and moderate-income Muslim countries, examining the feasibility of implementing this lay-led program.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Borama, Somalia
- Borama Mosque
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Hargeisa, Somalia
- Hargeisa Mosque
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Experienced a DSM-5 trauma at least 12 weeks ago
- Report current re-experiencing or avoidance symptoms
- Islamic faith
- 18-65 year of age
Exclusion Criteria:
- Immediate suicide risk, with intent or plan
- Cannot understand consent/visible cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PTSD lay-led group treatment program
The group will go through the Islamic Trauma Healing Program
|
6 session behavioral intervention program designed to reduce PTSD and related symptomatology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016)
Time Frame: Last 1 Week
|
PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016).
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.
|
Last 1 Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time Frame: Last 1 Week
|
The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.
Higher scores indicate greater depression severity, with scores ranging from 0 to 27.
|
Last 1 Week
|
Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)
Time Frame: Last 1 Week
|
The Somatic Symptoms Scale is an 8 item version of the PHQ-15; self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness).
The current version scored items on the original PHQ-15 scale from 0 to 2, with a range from 0 to 16.
|
Last 1 Week
|
Quality of Well-being Index
Time Frame: Last 1 Week
|
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, with higher scores reflecting better well-being.
Range of scores is from 0 to 25.
|
Last 1 Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lori Zoellner, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2018
Primary Completion (Actual)
February 6, 2019
Study Completion (Actual)
February 6, 2019
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
November 30, 2018
First Posted (Actual)
December 3, 2018
Study Record Updates
Last Update Posted (Actual)
November 21, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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