Posttraumatic Stress DisorderNCT00839813
Efficacy of Yoga for Treatment-Resistant Posttraumatic Stress Disorder
A study testing Yoga in people with Posttraumatic Stress Disorder, run by Justice Resource Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 58 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Trauma Center at JRI
Brookline, Massachusetts, 02446
Regina Musicaro, BA, 617-232-1303 ext. 310, rmusicaro@jri.org
Bessel van der Kolk, M.D.
About this study
Official title: 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:
- 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.
Read the 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.]
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Yoga
- Keywords
- Yoga, Posttraumatic Stress Disorder, PTSD, women's health
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
10 weeks of a trauma-sensitive yoga class
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 10 week trauma-sensitive yoga classes Receives: Behavioral: Yoga |
| Women's Health Education | No intervention | 10 weeks of women's health education classes as an attentional control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS 1)
Measured: Initial Assessment
Clinician Administered PTSD Scale (CAPS 1)
Measured: One week Pre-Treatment Evaluation
Clinician Administered PTSD Scale (CAPS 1)
Measured: One week Post-treatment
Clinician Administered PTSD Scale (CAPS 1)
Measured: 2 month-follow-up Evaluation
Secondary outcomes (1)
Heart Rate Variability
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Justice Resource Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Bessel van der Kolk, M.D., Principal investigator, The Trauma Center at JRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839813
- Sponsor's protocol ID
- R21AT003905-01A2
- Other IDs
- R21AT003905-01A2, 1R21AT003905-01A2
- Status last verified
- Apr 2011
- First submitted
- 9 Feb 2009
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32853015van 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.
PubMed 25004196
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yoga for Treatment-Resistant PTSD
- ClinicalTrials.gov ID
- NCT00839813
- Acronym / sponsor ID
- R21AT003905-01A2
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Yoga, Posttraumatic Stress Disorder, PTSD, women's health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Justice Resource InstituteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga10 week trauma-sensitive yoga classes |
| Women's Health Education | No intervention | –10 weeks of women's health education classes as an attentional control group |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga10 weeks of a trauma-sensitive yoga class | Behavioural | Yoga |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
- Derived from this study: PubMed 32853015Nguyen-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.
- Derived from this study: PubMed 25004196van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bessel van der Kolk, M.D. principal investigator
The Trauma Center at JRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Posttraumatic Stress Disorder, run by Justice Resource Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Musicaro, BA (617-232-1303 ext. 310, rmusicaro@traumacenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS 1) (time frame: Initial Assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00839813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.