Trial Outcomes & Findings for Islamic Trauma Healing: Feasibility Study (NCT NCT03761732)

Last Updated: 2023-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Last 1 Week

Results posted on

2023-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	PTSD Lay-led Group Treatment Program The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Islamic Trauma Healing: Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTSD Lay-led Group Treatment Program n=26 Participants The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Somalia	26 participants n=5 Participants
PTSD Severity (PDS-5)	30.88 score on a scale STANDARD_DEVIATION 13.76 • n=5 Participants
Depression Symptoms (PHQ-9)	10.42 score on a scale STANDARD_DEVIATION 4.69 • n=5 Participants
Somatic Symptoms (SSS-8)	8.46 score on a scale STANDARD_DEVIATION 2.53 • n=5 Participants
Well-Being (WHO-5)	10.00 score on a scale STANDARD_DEVIATION 6.62 • n=5 Participants

PRIMARY outcome

Timeframe: Last 1 Week

Outcome measures

Outcome measures
Measure	PTSD Lay-led Group Treatment Program n=26 Participants The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016)	8.08 score on a scale Standard Deviation 5.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PTSD Lay-led Group Treatment Program n=26 Participants The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	2.50 score on scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PTSD Lay-led Group Treatment Program n=26 Participants The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Somatic Symptoms Scale-8 (SSS-8; Gierk et al., 2014)	2.38 score on a scale Standard Deviation 1.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PTSD Lay-led Group Treatment Program n=26 Participants The group will go through the Islamic Trauma Healing Program Islamic Trauma Healing: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
Quality of Well-being Index	19.38 score on a scale Standard Deviation 2.48

Adverse Events

PTSD Lay-led Group Treatment Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Zoellner

University of Washington

Phone: 206 685 3617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place