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| ID | Type | Description | Link |
|---|---|---|---|
| 08144033 |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga treatment | Experimental |
| |
| Waitlist | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | pre-intervention and 10 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sat Bir S Khalsa, Ph.D. | Brigham and Women's Hospital | Principal Investigator |
| Jennifer Johnston, MA, LMHC | Northeastern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16281237 | Background | 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. | |
| 16507803 | Background | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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 |
| 11681550 | Background | 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. |
| 16891578 | Background | 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. |
| Background | Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998. |
| 6590525 | Background | 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. |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |