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

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ClinicalTrials.gov Identifier: NCT01595477
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : January 29, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Behavioral: Mind-Body Skills Group

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 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 Children in Gaza
Study Start Date : March 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012
Arms and Interventions

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

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. Hopelessness Scale for Children [ Time Frame: Change from Baseline (Week 1) at 6 weeks ]
  5. Hopelessness Scale for Children [ Time Frame: Change from Week 6 at 18 weeks ]
  6. Hopelessness Scale for Children [ Time Frame: Change from Baseline (Week 1) at 18 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 13 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): NCT01595477


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: NCT01595477     History of Changes
Other Study ID Numbers: GC-CMBM-001
First Posted: May 10, 2012    Key Record Dates
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