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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00839813 |
The central question in this research proposal is: can a popular technique that specifically targets active mastery and improved affect regulation, yoga, which is utilized by approximately 4% of the US population each year (1), improve the constellation of PTSD symptoms, multiple somatic complaints, social and occupational impairment and high health care utilization that has been documented in hundreds of thousands of women in the US?
The Primary Aims of this study include the following:
Condition | Intervention |
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Posttraumatic Stress Disorder |
Behavioral: Yoga |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Yoga for Treatment-Resistant PTSD |
Estimated Enrollment: | 64 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Yoga: Experimental
10 week trauma-sensitive yoga classes
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Behavioral: Yoga
10 weeks of a trauma-sensitive yoga class
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Women's Health Education: No Intervention
10 weeks of women's health education classes as an attentional control group
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Research has demonstrated a close association between trauma exposure and 1) PTSD, anxiety & depression, 2) loss of affect regulation, 3) poor quality of life, and 4) high health care utilization (2, 3). This study will explore how a popular body-mind technique, yoga, compares with a attentional control group condition, Women's Health Education (WHE), in the treatment of [heretofore treatment- unresponsive adults with] PTSD, and measure whether yoga can affect "the attitudes and beliefs" that "can reduce psychological stress and contribute to positive health outcomes." [The study of yoga for chronic PTSD is in line with the empirical research that supports the notion that autonomic dysregulation plays a significant role in the persistence of PTSD (4), and with the hypothesis that an increased capacity for self-regulation is associated with a decrease in the severity of this symptom constellation].
Primary aims.
Primary Hypotheses:
Yoga will be more effective than attention control at improving PTSD symptoms as evidenced by a significantly greater drop in total CAPS score from pre-treatment to post-treatment for the yoga group.
Secondary Hypotheses:
Ages Eligible for Study: | 18 Years to 58 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ritu Sharma, Ph.D. | 617-232-1303 ext 208 | rsharma@traumacenter.org |
Contact: Joseph Spinazzola, Ph.D. | 617-232-1303 | jspinazzola@jri.org |
United States, Massachusetts | |
The Trauma Center at JRI | Recruiting |
Brookline, Massachusetts, United States, 02446 | |
Contact: Ritu Sharma, Ph.D. 617-232-1303 ext 208 rsharma@jri.org | |
Principal Investigator: Bessel van der Kolk, M.D. |
Principal Investigator: | Bessel van der Kolk, M.D. | The Trauma Center at JRI |
Responsible Party: | The Trauma Center at JRI ( Bessel van der Kolk, MD ) |
Study ID Numbers: | 1R21AT003905-01A2, 1R21AT003905-01A2 |
Study First Received: | February 9, 2009 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00839813 History of Changes |
Health Authority: | United States: Federal Government |
Yoga Posttraumatic Stress Disorder PTSD women's health |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |