A Lay-Led Intervention for War and Refugee Related Trauma

NCT ID: NCT03502278

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-14

Study Completion Date

2022-07-14

Brief Summary

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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).

Detailed Description

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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.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTSD lay-led group treatment program

This group will go through the Islamic Trauma Healing Program

Group Type ACTIVE_COMPARATOR

Islamic Trauma Healing

Intervention Type BEHAVIORAL

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

Waitlist

Waitlist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Islamic Trauma Healing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Seattle Pacific University

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Lori Zoellner

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lori A Zoellner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Zoellner LA, Bentley JA, Musa K, Mohamed F, Ahmed LB, King KM, Feeny NC; Islamic Trauma Healing Clinical Team. Lay-Led Intervention for War and Refugee Trauma: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429661. doi: 10.1001/jamanetworkopen.2024.29661.

Reference Type DERIVED
PMID: 39186273 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R34MH112756

Identifier Type: NIH

Identifier Source: secondary_id

View Link

49606

Identifier Type: -

Identifier Source: org_study_id

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