Status:
COMPLETED
Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
United States Department of Defense
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yo...
Detailed Description
Specific Aims: 1. To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline ...
Eligibility Criteria
Inclusion
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Exclusion
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00962403
Start Date
August 1 2009
End Date
May 1 2012
Last Update
March 20 2013
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215