A Lay-Led Intervention for War and Refugee Related Trauma

PTSD Clinical Trial

Official title:

A Lay-Led Intervention for War and Refugee Related Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502278
• Other study ID #: 49606
• Secondary ID: 1R34MH112756
• Status: Completed
• Phase: N/A
• Start date: July 14, 2018
• Est. completion date: July 14, 2022

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 14, 2022
• Est. primary completion date: July 14, 2022
• 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

• Somali background

• Islamic faith

• 18-65 year of age

Exclusion Criteria:

• Immediate suicide risk, with intent or plan

• Cannot understand consent/visible cognitive impairment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Islamic Trauma Healing
A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Case Western Reserve University, National Institute of Mental Health (NIMH), Seattle Pacific University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Month Follow-up
Secondary	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.	3 Month Follow-up
Secondary	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) .	3 Month Follow-up
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.	3 Month Follow-up