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Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00839813
Recruitment Status : Unknown
Verified April 2011 by Justice Resource Institute.
Recruitment status was:  Recruiting
First Posted : February 10, 2009
Last Update Posted : April 6, 2011
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Justice Resource Institute

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date April 6, 2011
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: Initial Assessment ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: One week Pre-Treatment Evaluation ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: One week Post-treatment ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: 2 month-follow-up Evaluation ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder
Official Title  ICMJE 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:

  1. To test the short-term and long-term effectiveness of 10 weeks of yoga for treating treatment-resistant PTSD and compare it with attention controls receiving Women's Health Education (WHE).
  2. To assess the short-term and long-term effects of yoga on a) co-morbid conditions, b) quality of life, c) body awareness, d) health care utilization and e) heart rate variability (HRV), in comparison to an attention control group.
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.

  1. To test the short-term and long-term effectiveness of 10 weeks of yoga for treating treatment-resistant PTSD and compare it with attention controls receiving Women's Health Education (WHE).
  2. To assess the short-term and long-term effects of yoga on a) co-morbid conditions, b) quality of life, c) body awareness, d) health care utilization and e) heart rate variability (HRV), in comparison to an attention control group.

Primary Hypotheses:

  1. Participants in the yoga condition will demonstrate a clinically significant reduction in PTSD symptoms at post-treatment, defined as a mean reduction of total CAPS score of at least 30% compared to baseline.
  2. 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:

  3. Yoga will be more effective at improving comorbid conditions and quality of life and reducing health care utilization than attention control.
  4. Yoga will be more effective than attention control at improving HRV and body awareness.]
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE Behavioral: Yoga
10 weeks of a trauma-sensitive yoga class
Study Arms  ICMJE
  • Experimental: Yoga
    10 week trauma-sensitive yoga classes
    Intervention: Behavioral: Yoga
  • No Intervention: Women's Health Education
    10 weeks of women's health education classes as an attentional control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women between 18 and 58 years old, any race
  • Chronic, treatment-unresponsive PTSD
  • An index trauma that occurred 12 or more years before initial interview
  • At least 3 years of prior treatment focused on dealing with the consequences of the index trauma
  • Comorbid diagnoses of depression or panic disorder, which are common in subjects with PTSD, will be permitted

Exclusion Criteria:

  • Medical: Serious illness (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) that is not stabilized based on the judgment of the PI.
  • Psychological: GAF < 40.
  • Bipolar disorders, obsessive-compulsive disorder [OCD], schizophrenia, and any psychotic disorder will be excluded if they occurred any time prior to the primary traumatic episode
  • Current psychotic disorder, or established organic impairment (e.g., TBI)
  • Severe dissociation, as measured by a DES score >25.
  • Women with active suicidal risk, active self-mutilation or aggressive behavior toward others within the past year, as judged by the PI
  • Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria and judged by the PI.
  • Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol.
  • Legal and Financial: Current legal proceedings resulting from the traumatic events. People whose continued receipt of financial benefits is contingent upon maintaining PTSD symptoms or who are waiting for a decision concerning the receipt of financial benefits based upon PTSD symptoms
  • Prior Yoga Experience: Subjects who have attended more than five prior yoga sessions.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00839813
Other Study ID Numbers  ICMJE R21AT003905-01A2( U.S. NIH Grant/Contract )
R21AT003905-01A2 ( U.S. NIH Grant/Contract )
1R21AT003905-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bessel van der Kolk, MD, The Trauma Center at JRI
Study Sponsor  ICMJE Justice Resource Institute
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Bessel van der Kolk, M.D. The Trauma Center at JRI
PRS Account Justice Resource Institute
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP