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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinician Administered PTSD Scale (CAPS)
Time frame: pre-intervention and 10 weeks
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
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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