Recruiting

Yoga

Sponsor:

Justice Resource Institute

Code:

NCT00839813

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 58

Healthy Volunteers: Not accepted

Interventions

Yoga

Study Details

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT00839813

Start date

Nov, 2008

Status verified date

Apr, 2011

Completion date

May, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 58

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Yoga

10 week trauma-sensitive yoga classes

no intervention: Women's Health Education

10 weeks of women's health education classes as an attentional control group

Interventions

Yoga

10 weeks of a trauma-sensitive yoga class

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Regina Musicaro, BA

617-232-1303rmusicaro@traumacenter.org

Joseph Spinazzola, Ph.D.

617-232-1303jspinazzola@jri.org

Locations

The Trauma Center at JRI

Recruiting

Brookline, Massachusetts, United States, 02446

Contacts

Regina Musicaro, BA

617-232-1303rmusicaro@jri.org

Principal Investigator:

Bessel van der Kolk, M.D.

More Information

Sponsor

Justice Resource Institute

Last update posted

Apr 6, 2011

Last verified

Apr, 2011

Keywords

  • Yoga
  • Posttraumatic Stress Disorder
  • PTSD
  • women's health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Justice Resource Institute on 2011-04-06.