Post-Traumatic Stress DisorderEYIPTSDNCT00962403
Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
A study testing Yoga treatment in people with Post-Traumatic Stress Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Yoga treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Who cannot join
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
Read the detailed description
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Yoga treatment
- Keywords
- post traumatic stress disorder, yoga, meditation, military, veteran, trauma, stress, depression, anxiety, insomnia, autonomic
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga treatmentBehavioural
Also called Kripalu Yoga
The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions. In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
| Study group | Role | What they receive |
|---|---|---|
| Yoga treatment | Experimental | Not described Receives: Behavioral: Yoga treatment |
| Waitlist | No intervention | Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period. This study began as a single arm treatment trial and then transitioned to a randomized controlled trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Measured: pre-intervention and 10 weeks
Secondary outcomes (15)
PTSD Checklist Military Version (PCL-M)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Impact of Events Scale - Revised (IES-R)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
25-item Resilience Scale (RS)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Twenty-four-hour urinary samples
Measured: pre-intervention and 3 months post intervention
10-minute segment of a seated 30-minute electrocardiogram recording session
Measured: pre-intervention and 3 months post intervention
Beck Depression Inventory (BDI)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Spielberger State Trait Anxiety Inventory (STAI)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Daily Sleep Wake Diaries
Measured: during intervention (weeks 1-10) and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Credibility Expectancy Questionnaire (CEQ)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Body-Oriented State Questionnaire (BOSC)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
5-Facet Mindfulness Questionnaire (FFMQ)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Perceived Stress Scale (PSS)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Yoga Follow-up Questionnaire
Measured: 3 months post intervention
PTSD Checklist Civilian Version (PCL-C)
Measured: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Sat Bir Khalsa, PhD, Brigham and Women's Hospital
- Investigators
- Sat Bir S Khalsa, Ph.D., Principal investigator, Brigham and Women's HospitalJennifer Johnston, MA, LMHC, Study director, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962403
- Sponsor's protocol ID
- 2009-P-000717
- Other IDs
- 08144033
- Acronym
- EYIPTSD
- Status last verified
- Mar 2013
- First submitted
- 13 Aug 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
PubMed 16281237Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
PubMed 16507803Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
PubMed 11681550van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
PubMed 16891578Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
PubMed 6590525
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00962403
- Acronym / sponsor ID
- EYIPTSD / 2009-P-000717
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- post traumatic stress disorder, yoga, meditation, military, veteran, trauma, stress, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Aug 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 main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
Detailed description
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga treatment | Experimental | Behavioral: Yoga treatment |
| Waitlist | No intervention | –Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period. This study began as a single arm treatment trial and then transitioned to a randomized controlled trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Key exclusion criteria (2 listed)
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
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 |
|---|---|---|
| Yoga treatmentAlso: Kripalu YogaThe 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions. In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home. | Behavioural | Yoga treatment |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: pre-intervention and 10 weeks
15 secondary outcomes
PTSD Checklist Military Version (PCL-M)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Impact of Events Scale - Revised (IES-R)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
25-item Resilience Scale (RS)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Twenty-four-hour urinary samples
Time frame: pre-intervention and 3 months post intervention
10-minute segment of a seated 30-minute electrocardiogram recording session
Time frame: pre-intervention and 3 months post intervention
Beck Depression Inventory (BDI)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Spielberger State Trait Anxiety Inventory (STAI)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Daily Sleep Wake Diaries
Time frame: during intervention (weeks 1-10) and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Credibility Expectancy Questionnaire (CEQ)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Body-Oriented State Questionnaire (BOSC)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
5-Facet Mindfulness Questionnaire (FFMQ)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Perceived Stress Scale (PSS)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Yoga Follow-up Questionnaire
Time frame: 3 months post intervention
PTSD Checklist Civilian Version (PCL-C)
Time frame: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Background: PubMed 16281237van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
- Background: PubMed 16507803Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
- Background: PubMed 11681550Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
- Background: PubMed 16891578van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- BackgroundSeligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
- Background: PubMed 6590525Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
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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.
Sat Bir S Khalsa, Ph.D. principal investigator
Brigham and Women's Hospital
Jennifer Johnston, MA, LMHC study director
Northeastern University
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 treatment in people with Post-Traumatic Stress Disorder, run by Brigham and Women's Hospital 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 2 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: finished, as of the sponsor's last update on 20 Mar 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: pre-intervention and 10 weeks). 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 NCT00962403, which also lists 6 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 20 Mar 2013.