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

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ClinicalTrials.gov Identifier: NCT01595464
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

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Week 11 at 23 weeks ]
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Week 11 at 23 weeks ]
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Week 11 at 23 weeks ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza
Official Title  ICMJE A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza
Brief Summary The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress symptoms and depression, and will increase posttraumatic growth compared to a control group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE Behavioral: Mind-Body Skills Groups
Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
Study Arms  ICMJE
  • Experimental: Mind-Body Skills Groups
    Intervention: Behavioral: Mind-Body Skills Groups
  • No Intervention: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
148
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
154
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 PTSD Checklist- Civilian version

Exclusion Criteria:

  • former psychosocial or medical treatment for mental health conditions
  • significant cognitive impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595464
Other Study ID Numbers  ICMJE GA-CMBM-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James S. Gordon, M.D., The Center for Mind-Body Medicine
Study Sponsor  ICMJE The Center for Mind-Body Medicine
Collaborators  ICMJE The Atlantic Philanthropies
Investigators  ICMJE
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
PRS Account The Center for Mind-Body Medicine
Verification Date January 2014

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