A Lay-Led Intervention for War and Refugee Related Trauma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03502278|
Recruitment Status : Unknown
Verified May 2019 by Lori Zoellner, University of Washington.
Recruitment status was: Recruiting
First Posted : April 18, 2018
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Islamic Trauma Healing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A small RCT (N = 60) will be conducted comparing Islamic Trauma Healing in an U.S. Somali refugee sample to a waitlist control|
|Masking:||None (Open Label)|
|Official Title:||A Lay-Led Intervention for War and Refugee Related Trauma|
|Actual Study Start Date :||July 14, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Active Comparator: PTSD lay-led group treatment program
This group will go through the Islamic Trauma Healing Program
Behavioral: Islamic Trauma Healing
A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles
No Intervention: Waitlist
- PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015 [ Time Frame: 3 Month Follow-up ]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.
- Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) [ Time Frame: 3 Month Follow-up ]The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.
- Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002) [ Time Frame: 3 Month Follow-up ]The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .
- Quality of well-being Index [ Time Frame: 3 Month Follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502278
|Contact: Lori Zoellner, PhDfirstname.lastname@example.org|
|Contact: Ifrah Sheikh, MSemail@example.com|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106-7123|
|Contact: Norah C Feeny, PhD 216-368-2695 firstname.lastname@example.org|
|Principal Investigator: Norah C Feeny, PhD|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Lori Zoellner, PhD 206-685-3617 email@example.com|
|Principal Investigator: Lori A Zoellner, PhD|
|Principal Investigator: Jacob A Bentley, PhD|
|Principal Investigator:||Lori A Zoellner, PhD||University of Washington|