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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014