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

This study has been completed.
Sponsor:
Collaborator:
The Atlantic Philanthropies
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier:
NCT01595477
First received: May 8, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Behavioral: Mind-Body Skills Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Center for Mind-Body Medicine:

Primary Outcome Measures:
  • Child PTSD Symptom Scale [ Time Frame: Change from Baseline (Week 1) at 6 weeks ] [ Designated as safety issue: No ]
  • Child PTSD Symptom Scale [ Time Frame: Change from Week 6 at 18 weeks ] [ Designated as safety issue: No ]
  • Child PTSD Symptom Scale [ Time Frame: Change from Baseline (Week 1) at 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Baseline (Week 1) at 6 weeks ] [ Designated as safety issue: No ]
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Week 6 at 18 weeks ] [ Designated as safety issue: No ]
  • Children's Depression Inventory -2 Short Form [ Time Frame: Change from Baseline (Week 1) at 18 weeks ] [ Designated as safety issue: No ]
  • Hopelessness Scale for Children [ Time Frame: Change from Baseline (Week 1) at 6 weeks ] [ Designated as safety issue: No ]
  • Hopelessness Scale for Children [ Time Frame: Change from Week 6 at 18 weeks ] [ Designated as safety issue: No ]
  • Hopelessness Scale for Children [ Time Frame: Change from Baseline (Week 1) at 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 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

Ages Eligible for Study:   8 Months to 13 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: May 8, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014