NCT03761732

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

November 14, 2018

Results QC Date

July 16, 2021

Last Update Submit

February 20, 2023

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

    Last 1 Week

  • Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)

    Last 1 Week

  • Quality of Well-being Index

    Last 1 Week

Study Arms (1)

PTSD lay-led group treatment program

EXPERIMENTAL

The group will go through the Islamic Trauma Healing Program

Behavioral: Islamic Trauma Healing

Interventions

Islamic Trauma HealingBEHAVIORAL

6 session behavioral intervention program designed to reduce PTSD and related symptomatology

PTSD lay-led group treatment program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experienced a DSM-5 trauma at least 12 weeks ago
  • Report current re-experiencing or avoidance symptoms
  • Islamic faith
  • year of age

You may not qualify if:

  • Immediate suicide risk, with intent or plan
  • Cannot understand consent/visible cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Borama Mosque

Borama, Somalia

Location

Hargeisa Mosque

Hargeisa, Somalia

Location

Related Publications (2)

  • Klein AB, Egeh MH, Bowling AR, Holloway A, Ali AA, Abdillahi ZA, Abdi MA, Ibrahim SH, Bootan KH, Ibrahim HI, Ali AM, Tubeec AM, Dolezal ML, Angula DA, Bentley JA, Feeny NC, Zoellner LA. WhatsApp supervision for a lay-led Islamic trauma-focused intervention in Somaliland: Qualitative content analysis. J Trauma Stress. 2023 Feb;36(1):59-70. doi: 10.1002/jts.22882. Epub 2022 Oct 6.

    PMID: 36204779DERIVED

  • 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.

    PMID: 34149468DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Lori Zoellner
Organization
University of Washington
ContactUWCATS@uw.edu
206 685 3617

Study Officials

  • Lori Zoellner, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2018

First Posted

December 3, 2018

Study Start

October 15, 2018

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

November 21, 2023

Results First Posted

November 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

SO(2)