Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	Department of Defense
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00962403

Purpose

The main objective of this study is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans. Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.

Condition	Intervention
Post-Traumatic Stress Disorder	Behavioral: Yoga treatment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Clinician Administered PTSD Scale (CAPS) [ Time Frame: pre-intervention and 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PTSD Checklist Military Version (PCL-M) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Impact of Events Scale - Revised (IES-R) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
25-item Resilience Scale (RS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Twenty-four-hour urinary samples [ Time Frame: pre-intervention and 3 months post intervention ] [ Designated as safety issue: No ]
10-minute segment of a seated 30-minute electrocardiogram recording session [ Time Frame: pre-intervention and 3 months post intervention ] [ Designated as safety issue: No ]
Beck Depression Inventory (BDI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Spielberger State Trait Anxiety Inventory (STAI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Daily Sleep Wake Diaries [ Time Frame: during intervention (weeks 1-10) and 3 months post intervention ] [ Designated as safety issue: No ]
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Credibility Expectancy Questionnaire (CEQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Body-Oriented State Questionnaire (BOSC) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
5-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Perceived Stress Scale (PSS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]
Yoga Follow-up Questionnaire [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Yoga treatment	Behavioral: Yoga treatment The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions. In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home. Other Name: Kripalu Yoga

Detailed Description:

Specific Aims:

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 evaluation.
To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

Potential subjects are ineligible if pregnant and in their third trimester.
Potential subjects are ineligible if they are confined to a wheel chair.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962403

Contacts

Contact: Kristen M Reinhardt, BA	(617) 525-8699	kreinhardt@rics.bwh.harvard.edu
Contact: Sat Bir S Khalsa, Ph.D.	(617) 732-7994	khalsa@hms.harvard.edu

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kristen M Reinhardt, BA 617-525-8699 kreinhardt@rics.bwh.harvard.edu
Contact: Sat Bir S Khalsa, Ph.D. (617) 732-7994 khalsa@hms.harvard.edu
Principal Investigator: Sat Bir S Khalsa, Ph.D.

Sponsors and Collaborators

Brigham and Women's Hospital

Department of Defense

Investigators

Principal Investigator:	Sat Bir S Khalsa, Ph.D.	Brigham and Women's Hospital
Study Director:	Jennifer Johnston, MA, LMHC	Northeastern University

More Information

Publications:

van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99.

Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32.

Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47.

van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. Review.

Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.

Responsible Party:	Sat Bir S. Khalsa, Ph.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00962403 History of Changes
Other Study ID Numbers:	2009-P-000717, 08144033
Study First Received:	August 13, 2009
Last Updated:	August 2, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

post traumatic stress disorder
yoga
meditation
military
veteran
trauma

stress
depression
anxiety
insomnia
autonomic

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012