Islamic Trauma Healing: Feasibility Study
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Somalia
Study Type
Interventional
Intervention
Islamic Trauma Healing
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
Eligibility Criteria
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
Sites / Locations
- Borama Mosque
- Hargeisa Mosque
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PTSD lay-led group treatment program
Arm Description
The group will go through the Islamic Trauma Healing Program
Outcomes
Primary Outcome Measures
PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015
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
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
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)
The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .
Quality of well-being Index
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
Full Information
NCT ID
NCT03761732
First Posted
November 14, 2018
Last Updated
May 20, 2019
Sponsor
University of Washington
Collaborators
Case Western Reserve University, Seattle Pacific University
1. Study Identification
Unique Protocol Identification Number
NCT03761732
Brief Title
Islamic Trauma Healing: Feasibility Study
Official Title
Islamic Trauma Healing: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Case Western Reserve University, Seattle Pacific University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 20) 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTSD lay-led group treatment program
Arm Type
Experimental
Arm Description
The group will go through the Islamic Trauma Healing Program
Intervention Type
Behavioral
Intervention Name(s)
Islamic Trauma Healing
Intervention Description
6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Primary Outcome Measure Information:
Title
PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015
Description
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.
Time Frame
Last 1 Week
Secondary Outcome Measure Information:
Title
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Description
The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.
Time Frame
Last 1 Week
Title
Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)
Description
The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .
Time Frame
Last 1 Week
Title
Quality of well-being Index
Description
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
Time Frame
Last 1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Zoellner, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borama Mosque
City
Borama
Country
Somalia
Facility Name
Hargeisa Mosque
City
Hargeisa
Country
Somalia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34149468
Citation
Zoellner LA, Bentley JA, Feeny NC, Klein AB, Dolezal ML, Angula DA, Egeh MH. Reaching the Unreached: Bridging Islam and Science to Treat the Mental Wounds of War. Front Psychiatry. 2021 Jun 2;12:599293. doi: 10.3389/fpsyt.2021.599293. eCollection 2021.
Results Reference
derived
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Islamic Trauma Healing: Feasibility Study
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