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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00962403
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : March 20, 2013
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Sat Bir Khalsa, PhD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE August 13, 2009
First Posted Date  ICMJE August 20, 2009
Last Update Posted Date March 20, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
Clinician Administered PTSD Scale (CAPS) [ Time Frame: pre-intervention and 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • PTSD Checklist Military Version (PCL-M) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Impact of Events Scale - Revised (IES-R) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • 25-item Resilience Scale (RS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Twenty-four-hour urinary samples [ Time Frame: pre-intervention and 3 months post intervention ]
  • 10-minute segment of a seated 30-minute electrocardiogram recording session [ Time Frame: pre-intervention and 3 months post intervention ]
  • Beck Depression Inventory (BDI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Spielberger State Trait Anxiety Inventory (STAI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Daily Sleep Wake Diaries [ Time Frame: during intervention (weeks 1-10) and 3 months post intervention ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Credibility Expectancy Questionnaire (CEQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Body-Oriented State Questionnaire (BOSC) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • 5-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Perceived Stress Scale (PSS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Yoga Follow-up Questionnaire [ Time Frame: 3 months post intervention ]
  • PTSD Checklist Civilian Version (PCL-C) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • PTSD Checklist Military Version (PCL-M) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Impact of Events Scale - Revised (IES-R) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • 25-item Resilience Scale (RS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Twenty-four-hour urinary samples [ Time Frame: pre-intervention and 3 months post intervention ]
  • 10-minute segment of a seated 30-minute electrocardiogram recording session [ Time Frame: pre-intervention and 3 months post intervention ]
  • Beck Depression Inventory (BDI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Spielberger State Trait Anxiety Inventory (STAI) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Daily Sleep Wake Diaries [ Time Frame: during intervention (weeks 1-10) and 3 months post intervention ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Credibility Expectancy Questionnaire (CEQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Body-Oriented State Questionnaire (BOSC) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • 5-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Perceived Stress Scale (PSS) [ Time Frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention ]
  • Yoga Follow-up Questionnaire [ Time Frame: 3 months post intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
Official Title  ICMJE Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Yoga treatment
    Intervention: Behavioral: 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2013)
108
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2009)
45
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962403
Other Study ID Numbers  ICMJE 2009-P-000717
08144033
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sat Bir Khalsa, PhD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Sat Bir S Khalsa, Ph.D. Brigham and Women's Hospital
Study Director: Jennifer Johnston, MA, LMHC Northeastern University
PRS Account Brigham and Women's Hospital
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP