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

January 27, 2014 updated by: James S. Gordon, M.D., The Center for Mind-Body Medicine

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Palestine
      • Gaza City, Palestine, Israel
        • The Center for Mind-Body Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD Checklist-Civilian Version
Time Frame: Change from Baseline (Week 1) at 11 weeks
Change from Baseline (Week 1) at 11 weeks
PTSD Checklist-Civilian Version
Time Frame: Change from Week 11 at 23 weeks
Change from Week 11 at 23 weeks
PTSD Checklist-Civilian Version
Time Frame: Change from Baseline (Week1) at 23 Weeks
Change from Baseline (Week1) at 23 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from Baseline (Week 1) at 11 weeks
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
Change from Week 11 at 23 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from Baseline (Week1) at 23 Weeks
Change from Baseline (Week1) at 23 Weeks
Posttraumatic Growth Inventory
Time Frame: Change from Baseline (Week 1) at 11 weeks
Change from Baseline (Week 1) at 11 weeks
Posttraumatic Growth Inventory
Time Frame: Change from Week 11 at 23 weeks
Change from Week 11 at 23 weeks
Posttraumatic Growth Inventory
Time Frame: Change from Baseline (Week1) at 23 Weeks
Change from Baseline (Week1) at 23 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Mind-Body Medicine

Collaborators

The Atlantic Philanthropies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (ESTIMATE)

May 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-CMBM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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