Post Traumatic Stress DisorderNCT01556074
Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)
A study testing Yoga treatment in people with Post Traumatic Stress Disorder and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Insomnia
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female adults at least 18 years of age.
- A DSM-IV-TR diagnosis of post-traumatic stress disorder (PTSD).
- Naïve to yoga and other meditative practices, defined as less than one hour per week for the past 6 months.
- Potential subjects receiving ongoing medical or psychological treatment are eligible, as long as treatment remains stable over the course of the study and does not include more than one hour weekly of mind-body medicine (strategies directly related to meditation and yoga).
- No more than 2 alcoholic or caffeinated drinks/day
- No illicit drug use
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- Potential subjects are eligible if they have been on stable dosage (not PRN) of medication for PTSD symptoms including sleep disturbances and any medication that may influence sleep for at least 6 weeks prior to the study, and be willing to continue with same dosage for the duration of the study.
- No current substance abuse, defined as diagnosis of substance abuse or dependence disorder within the past year, and/or in/outpatient treatment for substance abuse or dependence in the past 6 weeks.
- No transcontinental travel over the course of the study.
- No night-shift or rotating shift work over the course of the study.
- Insomnia based on the American Academy of Sleep Medicine's Research Diagnostic Criteria (RDC) for insomnia due to a mental health disorder
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02116
About this study
Official title: Evaluation of Yoga for Sleep Disturbances in Insomnia and Posttraumatic Stress Disorder
The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.
- Conditions
- Post Traumatic Stress Disorder, Insomnia
- Being tested
- Yoga treatment
- Keywords
- Post traumatic stress disorder, PTSD, Insomnia, Sleep, Yoga, Meditation, Mental Health, Sleep Quality, Actigraphy, Sleep Diaries, Autonomic, Social Health, Interoception, Attention Regulation, Emotion Regulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga treatmentBehavioural
Biweekly 90-minute group yoga classes for 8 weeks and on non-class days participants will be asked to devote 15 minutes per day to a prescribed home yoga practice.
| Study group | Role | What they receive |
|---|---|---|
| Yoga treatment | Experimental | Not described Receives: Behavioral: Yoga treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality measured by wrist actigraphy and daily sleep diaries
Measured: Averages of: 2-week pre-treatment baseline; last 2 weeks of treatment; 2-week long-term follow-up occuring 3-months post-treatment
Secondary outcomes (11)
Acceptability of yoga program as measured by a 2-item Yoga Evaluation Form (End) and a 2-item Yoga Evaluation Form (Followup)
Measured: One occurrence at 1 week following intervention, one occurrence at 3 months post-intervention
Treatment adherence as measured by attendance to group yoga classes and play count monitoring of mp3's for home practice on non-class days
Measured: Averages over duration of intervention (8 weeks total)
Accrual rate calculated from recruitment and consent information
Measured: Monthly for duration of recruitment period (expected to be 3 months per cohort, up to 6 to 9 months for 2 to 3 cohorts total)
Attrition rate calculated from disempanelment information
Measured: Monthly for duration of data collection and treatment (approximately 6 months per cohort, up to 18 months for 2 to 3 cohorts total)
Change in PTSD symptoms as measured by the 17-item, self-reported PTSD Checklist-- Civilian version (PCL-C)
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in 10-min segment of a seated 30-min electrocardiogram (ECG) recording
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in emotional distress as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for anxiety (4 items), depression (4 items) and anger (8 items)
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in social health as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for social functioning (4 items), social functioning satisfaction (4 items) and social isolation (6 items)
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in interoception as measured by the 32-item self-reported Multidimensional Assessment of Interoceptive Awareness scale (MAIA)
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS)
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in sleep disturbance and sleep-related impairment as measured by two PROMIS scales
Measured: Once at 1-week before intervention, once at 1 week post-intervention, once at 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 posted16 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Sat Bir Khalsa, PhD, Brigham and Women's Hospital
- Investigators
- Jessica J Noggle Taylor, PhD, Principal investigator, Emory UniversitySat Bir S Khalsa, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556074
- Sponsor's protocol ID
- 2012P000263
- Other IDs
- F32AT006092-01A1, 18180
- Status last verified
- Aug 2014
- First submitted
- 8 Mar 2012
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Yoga for Sleep Disturbances in Insomnia and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01556074
- Acronym / sponsor ID
- 2012P000263
- Conditions
- Post Traumatic Stress Disorder, Insomnia
- Keywords
- Post traumatic stress disorder, PTSD, Insomnia, Sleep, Yoga, Meditation, Mental Health, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Brain & Behavior Research Foundation
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Mar 2012 (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 primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga treatment | Experimental | Behavioral: Yoga treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and non-pregnant female adults at least 18 years of age.
- A DSM-IV-TR diagnosis of post-traumatic stress disorder (PTSD).
- Naïve to yoga and other meditative practices, defined as less than one hour per week for the past 6 months.
- Potential subjects receiving ongoing medical or psychological treatment are eligible, as long as treatment remains stable over the course of the study and does not include more than one hour weekly of mind-body medicine (strategies directly related to meditation and yoga).
- No more than 2 alcoholic or caffeinated drinks/day
Key exclusion criteria (1 listed)
- Potential subjects are ineligible if pregnant.
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 treatmentBiweekly 90-minute group yoga classes for 8 weeks and on non-class days participants will be asked to devote 15 minutes per day to a prescribed home yoga practice. | Behavioural | Yoga treatment |
Primary outcome
Change in sleep quality measured by wrist actigraphy and daily sleep diaries
Time frame: Averages of: 2-week pre-treatment baseline; last 2 weeks of treatment; 2-week long-term follow-up occuring 3-months post-treatment
11 secondary outcomes
Acceptability of yoga program as measured by a 2-item Yoga Evaluation Form (End) and a 2-item Yoga Evaluation Form (Followup)
Time frame: One occurrence at 1 week following intervention, one occurrence at 3 months post-intervention
Treatment adherence as measured by attendance to group yoga classes and play count monitoring of mp3's for home practice on non-class days
Time frame: Averages over duration of intervention (8 weeks total)
Accrual rate calculated from recruitment and consent information
Time frame: Monthly for duration of recruitment period (expected to be 3 months per cohort, up to 6 to 9 months for 2 to 3 cohorts total)
Attrition rate calculated from disempanelment information
Time frame: Monthly for duration of data collection and treatment (approximately 6 months per cohort, up to 18 months for 2 to 3 cohorts total)
Change in PTSD symptoms as measured by the 17-item, self-reported PTSD Checklist-- Civilian version (PCL-C)
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in 10-min segment of a seated 30-min electrocardiogram (ECG) recording
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in emotional distress as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for anxiety (4 items), depression (4 items) and anger (8 items)
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in social health as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for social functioning (4 items), social functioning satisfaction (4 items) and social isolation (6 items)
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in interoception as measured by the 32-item self-reported Multidimensional Assessment of Interoceptive Awareness scale (MAIA)
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS)
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention
Change in sleep disturbance and sleep-related impairment as measured by two PROMIS scales
Time frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 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 4 Aug 2014.
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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.
Jessica J Noggle Taylor, PhD principal investigator
Emory University
Sat Bir S Khalsa, PhD principal investigator
Brigham and Women's Hospital
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 and Insomnia, 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 12 inclusion and 1 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 4 Aug 2014. 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?
Change in sleep quality measured by wrist actigraphy and daily sleep diaries (time frame: Averages of: 2-week pre-treatment baseline; last 2 weeks of treatment; 2-week long-term follow-up occuring 3-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2014.