- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302984
Mind-body Skills Groups for War-Related Trauma in Adolescents in Gaza
Mind-body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza: A Randomized Controlled Study
The goal of this clinical trial is to learn if mind-body skills groups can reduce posttraumatic stress disorder and emotional and behavioral problems in war-traumatized adolescents in Gaza.
The main questions it aims to answer are:
- Do mind-body skills groups reduce posttraumatic stress disorder symptoms in war-traumatized adolescents in Gaza?
- Do mind-body skills groups reduce emotional and behavioral problems in war-traumatized adolescents in Gaza?
Researchers will compare the results of adolescents who do not attend mind-body skills groups to adolescents who attend mind-body skills groups see if those who attend groups have less posttraumatic stress disorder symptoms and emotional and behavioral problems.
Participants will:
- Be screened to determine whether they qualify to be in the study
- If they qualify, they will attend 5 mind-body skills group sessions (if they are not in the control group)
- Fill out research packets before the first session, after the last session, and at 2-month follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jamil A Atti, PhD
- Phone Number: +972 (8) 288 8359
- Email: jatti@cmbm.org
Study Locations
-
-
-
Deir al-Balah, Palestinian Territories, P920
- Recruiting
- The Center for Mind-Body Medicine
-
Contact:
- Jamil A Atti, PhD
- Phone Number: +972 (8) 288 8359
- Email: jatti@cmbm.org
-
Principal Investigator:
- Jamil A Atti, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being 11-17 years old and living in Gaza
- having experienced a political violence or war-related criterion A stressor
- meeting the American Psychiatric Association (APA) Diagnostic and Statistical Manual-(DSM-5-TR) criteria for PTSD according to the screening cut-off score on the Child PTSD Symptom Scale-5 (CPSS-5).
Exclusion Criteria:
- former psychotherapy or medication to treat mental disorders
- having significant cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait List Control
|
|
|
Experimental: Mind-Body Skills Groups
|
Small group intervention consisting of guided imagery, slow deep breathing, autogenic training, drawings, and active techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Post-Traumatic Stress Disorder Symptom Scale - 5
Time Frame: Before first group session, 2 weeks, 2 months
|
Self-report Post-Traumatic Stress Disorder symptom scale with scores from 0 to 80. Higher scores indicate worse outcomes.
|
Before first group session, 2 weeks, 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Youth Pediatric Symptom Checklist-17
Time Frame: Before first group session, 2 weeks, 2 months
|
Assessment of Psychosocial Functioning with score range 0 - 34.
Higher scores indicate worse outcomes.
|
Before first group session, 2 weeks, 2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Julie K. Staples, PhD, The Center for Mind-Body Medicine
Publications and helpful links
General Publications
- Staples JK, Abdel Atti JA, Gordon JS. Mind-body skills groups for posttraumatic stress disorder and depression symptoms in Palestinian children and adolescents in Gaza. Int J Stress Manag. 2011; 18(3): 246-262. doi:/10.1037/trm0000081
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GT-CMBM-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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