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Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595490
First Posted: May 10, 2012
Last Update Posted: January 29, 2014
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.
Collaborator:
The Atlantic Philanthropies
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine
  Purpose
The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic stress symptoms, depression, and levels of aggression compared to a control group.

Condition Intervention
Posttraumatic Stress Disorder Behavioral: Mind-Body Skills Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza

Further study details as provided by James S. Gordon, M.D., The Center for Mind-Body Medicine:

Primary Outcome Measures:
  • Child PTSD Symptom Scale [ Time Frame: Change from Baseline (Week 1) at 6 weeks ]
  • Child PTSD Symptom Scale [ Time Frame: Change from Week 6 at 18 weeks ]
  • Child PTSD Symptom Scale [ Time Frame: Change from Baseline (Week 1) at 18 weeks ]

Secondary Outcome Measures:
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Baseline (Week 1) at 6 weeks ]
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Week 6 at 18 weeks ]
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Baseline (Week 1) at 18 weeks ]
  • Aggression Questionnaire [ Time Frame: Change from Baseline (Week 1) at 6 weeks ]
  • Aggression Questionnaire [ Time Frame: Change from Week 6 at 18 weeks ]
  • Aggression Questionnaire [ Time Frame: Change from Baseline (Week 1) at 18 weeks ]

Enrollment: 121
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mind-Body Skills Groups Behavioral: Mind-Body Skills Group
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
No Intervention: Control Group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01595490


Locations
Israel
The Center for MInd-Body Medicine
Gaza City, Palestine, Israel
Sponsors and Collaborators
The Center for Mind-Body Medicine
The Atlantic Philanthropies
Investigators
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
  More Information

Additional Information:
Responsible Party: James S. Gordon, M.D., Founder and Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT01595490     History of Changes
Other Study ID Numbers: GT-CMBM-001
First Submitted: May 8, 2012
First Posted: May 10, 2012
Last Update Posted: January 29, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
War-Related Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Wounds and Injuries