Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00839813

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:

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).
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

MedlinePlus related topics: Post-Traumatic Stress Disorder Women's Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Yoga for Treatment-Resistant PTSD

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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 ]

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
Yoga: Experimental 10 week trauma-sensitive yoga classes	Behavioral: Yoga 10 weeks of a trauma-sensitive yoga class
Women's Health Education: No Intervention 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.

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).
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:

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.
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:
Yoga will be more effective at improving comorbid conditions and quality of life and reducing health care utilization than attention control.
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

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

Contacts

Contact: Ritu Sharma, Ph.D.	617-232-1303 ext 208	rsharma@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: Ritu Sharma, Ph.D. 617-232-1303 ext 208 rsharma@jri.org
Principal Investigator: Bessel van der Kolk, M.D.

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Bessel van der Kolk, M.D.

The Trauma Center at JRI

More Information

No publications provided

Responsible Party:	The Trauma Center at JRI ( Bessel van der Kolk, MD )
Study ID Numbers:	1R21AT003905-01A2, 1R21AT003905-01A2
Study First Received:	February 9, 2009
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00839813 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Yoga
Posttraumatic Stress Disorder
PTSD
women's health

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 06, 2009