Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

— EYIPTSD  

Official title:

Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962403
• Other study ID #: 2009-P-000717
• Secondary ID: 08144033
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: March 19, 2013
• Start date: August 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.

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. — View Citation

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

Outcome

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