Clinical trial NCT00962403: Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
Official title: Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: post traumatic stress disorder
yoga
meditation
military
veteran
trauma
stress
depression
anxiety
insomnia
autonomic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-08-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: pre-intervention and 10 weeks
Secondary outcomes:
measure: PTSD Checklist Military Version (PCL-M)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: 25-item Resilience Scale (RS)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Twenty-four-hour urinary samples
timeFrame: pre-intervention and 3 months post intervention
measure: 10-minute segment of a seated 30-minute electrocardiogram recording session
timeFrame: pre-intervention and 3 months post intervention
measure: Beck Depression Inventory (BDI)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Spielberger State Trait Anxiety Inventory (STAI)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Daily Sleep Wake Diaries
timeFrame: during intervention (weeks 1-10) and 3 months post intervention
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Body-Oriented State Questionnaire (BOSC)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: 5-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Perceived Stress Scale (PSS)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
measure: Yoga Follow-up Questionnaire
timeFrame: 3 months post intervention
measure: PTSD Checklist Civilian Version (PCL-C)
timeFrame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sat Bir S Khalsa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Jennifer Johnston, MA, LMHC
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/jts.20047.
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. doi: 10.1001/jama.295.9.1023.
citation: 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. doi: 10.1017/s0033291701004287.
citation: van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
citation: Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
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. No abstract available.