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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03761732
Other study ID # STUDY00005522
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date February 6, 2019

Study information

Verified date February 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 6, 2019
Est. primary completion date February 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Islamic Trauma Healing
6 session behavioral intervention program designed to reduce PTSD and related symptomatology

Locations

Country Name City State
Somalia Borama Mosque Borama
Somalia Hargeisa Mosque Hargeisa

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Case Western Reserve University, Seattle Pacific University

Country where clinical trial is conducted

Somalia, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016) 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 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. Higher scores indicate greater depression severity, with scores ranging from 0 to 27. Last 1 Week
Secondary Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014) 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
Secondary 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, with higher scores reflecting better well-being. Range of scores is from 0 to 25. Last 1 Week
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