- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595477
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
January 27, 2014 updated by: James S. Gordon, M.D., The Center for Mind-Body Medicine
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in Gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Palestine
-
Gaza City, Palestine, Israel
- The Center for Mind-Body Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- having experienced a political violence or war-related criterion A stressor
- meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale
Exclusion Criteria:
- former psychosocial or medical treatment for mental health conditions
- significant cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Control Group
|
|
Experimental: Mind-Body Skills Groups
|
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child PTSD Symptom Scale
Time Frame: Change from Baseline (Week 1) at 6 weeks
|
Change from Baseline (Week 1) at 6 weeks
|
Child PTSD Symptom Scale
Time Frame: Change from Week 6 at 18 weeks
|
Change from Week 6 at 18 weeks
|
Child PTSD Symptom Scale
Time Frame: Change from Baseline (Week 1) at 18 weeks
|
Change from Baseline (Week 1) at 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's Depression Inventory -2 Short Form
Time Frame: Change from Baseline (Week 1) at 6 weeks
|
Change from Baseline (Week 1) at 6 weeks
|
Children's Depression Inventory -2 Short Form
Time Frame: Change from Week 6 at 18 weeks
|
Change from Week 6 at 18 weeks
|
Children's Depression Inventory -2 Short Form
Time Frame: Change from Baseline (Week 1) at 18 weeks
|
Change from Baseline (Week 1) at 18 weeks
|
Hopelessness Scale for Children
Time Frame: Change from Baseline (Week 1) at 6 weeks
|
Change from Baseline (Week 1) at 6 weeks
|
Hopelessness Scale for Children
Time Frame: Change from Week 6 at 18 weeks
|
Change from Week 6 at 18 weeks
|
Hopelessness Scale for Children
Time Frame: Change from Baseline (Week 1) at 18 weeks
|
Change from Baseline (Week 1) at 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 8, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 10, 2012
Study Record Updates
Last Update Posted (Estimate)
January 29, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GC-CMBM-001
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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