Back to resultsEvaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Post Traumatic Stress Disorder, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga treatment
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post traumatic stress disorder, PTSD, Insomnia, Sleep, Yoga, Meditation, Mental Health, Sleep Quality, Actigraphy, Sleep Diaries, Autonomic, Social Health, Interoception, Attention Regulation, Emotion Regulation
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- Potential subjects are ineligible if pregnant.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in sleep quality measured by wrist actigraphy and daily sleep diaries
Secondary Outcome Measures
Acceptability of yoga program as measured by a 2-item Yoga Evaluation Form (End) and a 2-item Yoga Evaluation Form (Followup)
Treatment adherence as measured by attendance to group yoga classes and play count monitoring of mp3's for home practice on non-class days
Accrual rate calculated from recruitment and consent information
Attrition rate calculated from disempanelment information
Change in PTSD symptoms as measured by the 17-item, self-reported PTSD Checklist-- Civilian version (PCL-C)
Change in 10-min segment of a seated 30-min electrocardiogram (ECG) recording
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)
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)
Change in interoception as measured by the 32-item self-reported Multidimensional Assessment of Interoceptive Awareness scale (MAIA)
Change in emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS)
Change in sleep disturbance and sleep-related impairment as measured by two PROMIS scales
Full Information
NCT ID
NCT01556074
First Posted
March 8, 2012
Last Updated
August 1, 2014
Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01556074
Brief Title
Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)
Official Title
Evaluation of Yoga for Sleep Disturbances in Insomnia and Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Brain & Behavior Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Insomnia
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Yoga treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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)
Title
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)
Title
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)
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
- Potential subjects are ineligible if pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica J Noggle Taylor, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sat Bir S Khalsa, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
12. IPD Sharing Statement
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Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)
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