Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder
2 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedApril 6, 2011
April 1, 2011
2.5 years
February 9, 2009
April 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Clinician Administered PTSD Scale (CAPS 1)
Initial Assessment
Clinician Administered PTSD Scale (CAPS 1)
One week Pre-Treatment Evaluation
Clinician Administered PTSD Scale (CAPS 1)
One week Post-treatment
Clinician Administered PTSD Scale (CAPS 1)
2 month-follow-up Evaluation
Secondary Outcomes (1)
Heart Rate Variability
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
Study Arms (2)
Yoga
EXPERIMENTAL10 week trauma-sensitive yoga classes
Women's Health Education
NO INTERVENTION10 weeks of women's health education classes as an attentional control group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Trauma Center at JRI
Brookline, Massachusetts, 02446, United States
Related Publications (2)
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.
PMID: 32853015DERIVEDvan 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.
PMID: 25004196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bessel van der Kolk, M.D.
The Trauma Center at JRI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
November 1, 2008
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 6, 2011
Record last verified: 2011-04