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Completed

NCT Number: NCT00962403

Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

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.

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Key information

About this study

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 and to a waitlist control group.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga treatment

Behavioral

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 names: Kripalu Yoga

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS)

    Time frame: pre-intervention and 10 weeks

Secondary outcomes

  1. PTSD Checklist Military Version (PCL-M)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  2. Impact of Events Scale - Revised (IES-R)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  3. 25-item Resilience Scale (RS)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  4. Twenty-four-hour urinary samples

    Time frame: pre-intervention and 3 months post intervention

  5. 10-minute segment of a seated 30-minute electrocardiogram recording session

    Time frame: pre-intervention and 3 months post intervention

  6. Beck Depression Inventory (BDI)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  7. Spielberger State Trait Anxiety Inventory (STAI)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  8. Daily Sleep Wake Diaries

    Time frame: during intervention (weeks 1-10) and 3 months post intervention

  9. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  10. Credibility Expectancy Questionnaire (CEQ)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  11. Body-Oriented State Questionnaire (BOSC)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  12. 5-Facet Mindfulness Questionnaire (FFMQ)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  13. Perceived Stress Scale (PSS)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

  14. Yoga Follow-up Questionnaire

    Time frame: 3 months post intervention

  15. PTSD Checklist Civilian Version (PCL-C)

    Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: EYIPTSD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2009
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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