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Tracking Information | |||||||||
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First Received Date † | February 9, 2009 | ||||||||
Last Updated Date | February 9, 2009 | ||||||||
Start Date † | November 2008 | ||||||||
Current Primary Outcome Measures † |
Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: 1. Initial Assessment 2. One week Pre-Treatment Evaluation 3. One week Post-treatment 4. 2 month-follow-up Evaluation ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
Heart Rate Variability [ Time Frame: Initial Assessment, week 1 of treatment, week 2 of treatment, week 5 of treatment, week 9 of treatment, week 10 of treatment, one week post-treatment, 2 month follow-up ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder | ||||||||
Official Title † | Efficacy of Yoga for Treatment-Resistant PTSD | ||||||||
Brief Summary | 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:
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Detailed Description | 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:
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Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
Condition † | Posttraumatic Stress Disorder | ||||||||
Intervention † | Behavioral: Yoga | ||||||||
Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 64 | ||||||||
Estimated Completion Date | May 2011 | ||||||||
Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years to 58 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00839813 | ||||||||
Responsible Party | Bessel van der Kolk, MD, The Trauma Center at JRI | ||||||||
Secondary IDs †† | 1R21AT003905-01A2 | ||||||||
Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |