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Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Sat Bir Khalsa, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00962403
First received: August 13, 2009
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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 yoga treatment (waitlist control) group. 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: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Resource links provided by NLM:

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 ]
  • PTSD Checklist Civilian Version (PCL-C) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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
No Intervention: Waitlist
Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period. This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.

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 evaluation and to a waitlist control group.
  2. To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
  3. To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
  4. 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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
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:

Responsible Party: Sat Bir Khalsa, PhD, Study Principal Investigator, 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: March 19, 2013
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 May 21, 2013