Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 8, 2012
January 27, 2014
March 2012
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01595477 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Posttraumatic Stress Disorder
Behavioral: Mind-Body Skills Group
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
  • Experimental: Mind-Body Skills Groups
    Intervention: Behavioral: Mind-Body Skills Group
  • No Intervention: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
8 Months to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01595477
GC-CMBM-001
No
James S. Gordon, M.D., The Center for Mind-Body Medicine
The Center for Mind-Body Medicine
The Atlantic Philanthropies
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
The Center for Mind-Body Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP