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

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ClinicalTrials.gov Identifier: NCT01595490
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : January 29, 2014
Sponsor:
Collaborator:
The Atlantic Philanthropies
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Mind-Body Skills Group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
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


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

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

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

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Responsible Party: James S. Gordon, M.D., Founder and Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT01595490    
Other Study ID Numbers: GT-CMBM-001
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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War-Related Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
 Trauma and Stressor Related Disorders
Mental Disorders
Wounds and Injuries