NCT03761732

Islamic Trauma Healing: Feasibility Study

Completed NA Results posted Last updated 21 November 2023

What this trial tests

NA trial testing Islamic Trauma Healing in Post Traumatic Stress Disorder in 28 participants. Completed in 6 February 2019.

Timeline

15 October 2018

Primary endpoint
6 February 2019

6 February 2019

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	15 October 2018
Primary completion	6 February 2019
Estimated completion	6 February 2019
Sites	2 locations across Somalia

Drugs / interventions tested

• Islamic Trauma Healing

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

University of Washington

Who can join

Adults 18 to 65, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016) Primary · Last 1 Week

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.

Group	Value	95% CI
PTSD Lay-led Group Treatment Program	8.08	± 5.74

Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) Secondary · Last 1 Week

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.

Group	Value	95% CI
PTSD Lay-led Group Treatment Program	2.50	± 1.50

Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014) Secondary · Last 1 Week

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.

Group	Value	95% CI
PTSD Lay-led Group Treatment Program	2.38	± 1.58

Quality of Well-being Index Secondary · Last 1 Week

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.

Group	Value	95% CI
PTSD Lay-led Group Treatment Program	19.38	± 2.48

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reaching the Unreached: Bridging Islam and Science to Treat the Mental Wounds of War.
   Zoellner LA, Bentley JA, Feeny NC, Klein AB, et al · · 2021 · cited 14× · PMID 34149468 · DOI 10.3389/fpsyt.2021.599293