Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Study Overview
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Brief Summary
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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
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Specific Aims: 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. To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment. To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved. 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.

Official Title
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Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Yoga treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga treatment<br> | Behavioral: Yoga treatment<br>* 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.<br>* Other names: Kripalu Yoga;|
| No Intervention: Waitlist<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) |  | pre-intervention and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist Military Version (PCL-M) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Impact of Events Scale - Revised (IES-R) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| 25-item Resilience Scale (RS) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Twenty-four-hour urinary samples |  | pre-intervention and 3 months post intervention | 
| 10-minute segment of a seated 30-minute electrocardiogram recording session |  | pre-intervention and 3 months post intervention | 
| Beck Depression Inventory (BDI) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Spielberger State Trait Anxiety Inventory (STAI) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Daily Sleep Wake Diaries |  | during intervention (weeks 1-10) and 3 months post intervention | 
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Credibility Expectancy Questionnaire (CEQ) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Body-Oriented State Questionnaire (BOSC) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| 5-Facet Mindfulness Questionnaire (FFMQ) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Perceived Stress Scale (PSS) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 
| Yoga Follow-up Questionnaire |  | 3 months post intervention | 
| PTSD Checklist Civilian Version (PCL-C) |  | pre-intervention, 5 weeks, 10 weeks and 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post traumatic stress disorder, yoga, meditation, military, veteran, trauma, stress, depression, anxiety, insomnia, autonomic