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

This study is currently recruiting participants.
Verified May 2012 by The Center for Mind-Body Medicine
Sponsor:
Collaborator:
The Atlantic Philanthropies
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier:
NCT01595464
First received: May 8, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
 Behavioral: Mind-Body Skills Groups

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 Adults in Gaza

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week 1) at 11 weeks ] [ Designated as safety issue: No ]
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Week 11 at 23 weeks ] [ Designated as safety issue: No ]
  • PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week1) at 23 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week 1) at 11 weeks ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Week 11 at 23 weeks ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week1) at 23 Weeks ] [ Designated as safety issue: No ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week 1) at 11 weeks ] [ Designated as safety issue: No ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Week 11 at 23 weeks ] [ Designated as safety issue: No ]
  • Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week1) at 23 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: March 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mind-Body Skills Groups Behavioral: Mind-Body Skills Groups
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:   18 Years and older
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 PTSD Checklist- Civilian version

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: NCT01595464

Contacts
Contact: Jamil Atti, MS jamil@cmbm.org

Locations
Israel
The Center for Mind-Body Medicine Recruiting
Gaza City, Palestine, Israel
Contact: Jamil Atti, MS         jamil@cmbm.org    
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:
The Center for Mind-Body Medicine website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: James S. Gordon, M.D., Founder and Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT01595464     History of Changes
Other Study ID Numbers: GA-CMBM-001
Study First Received: May 8, 2012
Last Updated: May 8, 2012
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 May 19, 2013