Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Justice Resource Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Justice Resource Institute
ClinicalTrials.gov Identifier:
NCT00839813
First received: February 9, 2009
Last updated: April 4, 2011
Last verified: April 2011

February 9, 2009
April 4, 2011
November 2008
May 2011   (final data collection date for primary outcome measure)
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: Initial Assessment ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: One week Pre-Treatment Evaluation ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: One week Post-treatment ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS 1) [ Time Frame: 2 month-follow-up Evaluation ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00839813 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder
Efficacy of Yoga for Treatment-Resistant PTSD

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.

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.]
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
Behavioral: Yoga
10 weeks of a trauma-sensitive yoga class
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 58 Years
No
Contact: Regina Musicaro, BA 617-232-1303 ext 310 rmusicaro@traumacenter.org
Contact: Joseph Spinazzola, Ph.D. 617-232-1303 jspinazzola@jri.org
United States
 
NCT00839813
R21 AT003905-01A2, R21AT003905-01A2, 1R21AT003905-01A2
Yes
Bessel van der Kolk, MD, The Trauma Center at JRI
Justice Resource Institute
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Bessel van der Kolk, M.D. The Trauma Center at JRI
Justice Resource Institute
April 2011

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