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Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans

Primary Purpose

Stress Disorders, Posttraumatic, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Posttraumatic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PTSD related to OEF/OIF service

Exclusion Criteria:

  • History of brain injury

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

MBSR

Outcomes

Primary Outcome Measures

PTSD symptom level measured with the CAPS

Secondary Outcome Measures

Full Information

First Posted
January 26, 2010
Last Updated
November 4, 2013
Sponsor
US Department of Veterans Affairs
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01058031
Brief Title
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans
Official Title
Neural Correlates of PTSD Prevention With MBSR in Iraqi Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Posttraumatic, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
MBSR
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
Mindfulness Based Stress Reduction
Primary Outcome Measure Information:
Title
PTSD symptom level measured with the CAPS
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTSD related to OEF/OIF service Exclusion Criteria: History of brain injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Bremner, MD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans

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