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Clinical Trials/NCT01595464
NCT01595464CompletedNot Applicable

A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza

The Center for Mind-Body Medicine1 site in 1 country148 target enrollmentStarted: March 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
148
Locations
1
Primary Endpoint
PTSD Checklist-Civilian Version

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

PTSD Checklist-Civilian Version

Time Frame: Change from Baseline (Week1) at 23 Weeks

Secondary Outcomes

  • Center for Epidemiological Studies Depression Scale (CES-D)(Change from Baseline (Week1) at 23 Weeks)
  • Posttraumatic Growth Inventory(Change from Baseline (Week1) at 23 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James S. Gordon, M.D.

Founder and Director

The Center for Mind-Body Medicine

Study Sites (1)

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