Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Yoga treatment
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Clinician Administered PTSD Scale (CAPS)
    • Time Frame: pre-intervention and 10 weeks
      Safety Issue?: No

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Department of Defense
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sat Bir Khalsa, PhD, Study Principal Investigator – Brigham and Women’s Hospital
  • Overall Official(s)
    • Sat Bir S Khalsa, Ph.D., Principal Investigator, Brigham and Women’s Hospital
    • Jennifer Johnston, MA, LMHC, Study Director, Northeastern University

References

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.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00962403