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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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Behavioral: Mind-Body Skills Groups

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  2. PTSD Checklist-Civilian Version [ Time Frame: Change from Week 11 at 23 weeks ]
  3. PTSD Checklist-Civilian Version [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]

Secondary Outcome Measures :
  1. Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  2. Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Week 11 at 23 weeks ]
  3. Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]
  4. Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week 1) at 11 weeks ]
  5. Posttraumatic Growth Inventory [ Time Frame: Change from Week 11 at 23 weeks ]
  6. Posttraumatic Growth Inventory [ Time Frame: Change from Baseline (Week1) at 23 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595464


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:
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
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
War-Related Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Wounds and Injuries