Trial record 13 of 7343 for:    Women's health

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
  Purpose

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.

Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Yoga for Treatment-Resistant PTSD

Resource links provided by NLM:


Further study details as provided by Justice Resource Institute:

Primary Outcome Measures:
  • 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 ]

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 ]

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
Experimental: Yoga
10 week trauma-sensitive yoga classes
Behavioral: Yoga
10 weeks of a trauma-sensitive yoga class
No Intervention: Women's Health Education
10 weeks of women's health education classes as an attentional 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.]
  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839813

Contacts
Contact: Regina Musicaro, BA 617-232-1303 ext 310 rmusicaro@traumacenter.org
Contact: Joseph Spinazzola, Ph.D. 617-232-1303 jspinazzola@jri.org

Locations
United States, Massachusetts
The Trauma Center at JRI Recruiting
Brookline, Massachusetts, United States, 02446
Contact: Regina Musicaro, BA    617-232-1303 ext 310    rmusicaro@jri.org   
Principal Investigator: Bessel van der Kolk, M.D.         
Sponsors and Collaborators
Justice Resource Institute
Investigators
Principal Investigator: Bessel van der Kolk, M.D. The Trauma Center at JRI
  More Information

No publications provided by Justice Resource Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bessel van der Kolk, MD, The Trauma Center at JRI
ClinicalTrials.gov Identifier: NCT00839813     History of Changes
Other Study ID Numbers: R21 AT003905-01A2, R21AT003905-01A2, 1R21AT003905-01A2
Study First Received: February 9, 2009
Last Updated: April 4, 2011
Health Authority: United States: Federal Government

Keywords provided by Justice Resource Institute:
Yoga
Posttraumatic Stress Disorder
PTSD
women's health

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014