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Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Justice Resource Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Yoga, Posttraumatic Stress Disorder, PTSD, women's health

Eligibility Criteria

18 Years - 58 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Trauma Center at JRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga

Women's Health Education

Arm Description

10 week trauma-sensitive yoga classes

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS 1)
Clinician Administered PTSD Scale (CAPS 1)
Clinician Administered PTSD Scale (CAPS 1)
Clinician Administered PTSD Scale (CAPS 1)

Secondary Outcome Measures

Heart Rate Variability

Full Information

First Posted
February 9, 2009
Last Updated
April 4, 2011
Sponsor
Justice Resource Institute
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00839813
Brief Title
Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder
Official Title
Efficacy of Yoga for Treatment-Resistant PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Justice Resource Institute
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.
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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Yoga, Posttraumatic Stress Disorder, PTSD, women's health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
10 week trauma-sensitive yoga classes
Arm Title
Women's Health Education
Arm Type
No Intervention
Arm Description
10 weeks of women's health education classes as an attentional control group
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
10 weeks of a trauma-sensitive yoga class
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS 1)
Time Frame
Initial Assessment
Title
Clinician Administered PTSD Scale (CAPS 1)
Time Frame
One week Pre-Treatment Evaluation
Title
Clinician Administered PTSD Scale (CAPS 1)
Time Frame
One week Post-treatment
Title
Clinician Administered PTSD Scale (CAPS 1)
Time Frame
2 month-follow-up Evaluation
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Musicaro, BA
Phone
617-232-1303
Ext
310
Email
rmusicaro@traumacenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Spinazzola, Ph.D.
Phone
617-232-1303
Email
jspinazzola@jri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bessel van der Kolk, M.D.
Organizational Affiliation
The Trauma Center at JRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Trauma Center at JRI
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Musicaro, BA
Phone
617-232-1303
Ext
310
Email
rmusicaro@jri.org
First Name & Middle Initial & Last Name & Degree
Bessel van der Kolk, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
32853015
Citation
Nguyen-Feng VN, Hodgdon H, Emerson D, Silverberg R, Clark CJ. Moderators of treatment efficacy in a randomized controlled trial of trauma-sensitive yoga as an adjunctive treatment for posttraumatic stress disorder. Psychol Trauma. 2020 Nov;12(8):836-846. doi: 10.1037/tra0000963. Epub 2020 Aug 27.
Results Reference
derived
PubMed Identifier
25004196
Citation
van der Kolk BA, Stone L, West J, Rhodes A, Emerson D, Suvak M, Spinazzola J. Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial. J Clin Psychiatry. 2014 Jun;75(6):e559-65. doi: 10.4088/JCP.13m08561.
Results Reference
derived

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Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder

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