Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder

April 4, 2011 updated by: Justice Resource Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02446
        • Recruiting
        • the Trauma Center at JRI
        • Contact:
        • Principal Investigator:
          • Bessel van der Kolk, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered PTSD Scale (CAPS 1)
Time Frame: Initial Assessment
Initial Assessment
Clinician Administered PTSD Scale (CAPS 1)
Time Frame: One week Pre-Treatment Evaluation
One week Pre-Treatment Evaluation
Clinician Administered PTSD Scale (CAPS 1)
Time Frame: One week Post-treatment
One week Post-treatment
Clinician Administered PTSD Scale (CAPS 1)
Time Frame: 2 month-follow-up Evaluation
2 month-follow-up Evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Justice Resource Institute

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Bessel van der Kolk, M.D., the Trauma Center at JRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 4, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT003905-01A2 (U.S. NIH Grant/Contract)
  • 1R21AT003905-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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