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| ID | Type | Description | Link |
|---|---|---|---|
| F32AT006092-01A1 | U.S. NIH Grant/Contract | View source | |
| 18180 | Other Grant/Funding Number | BBRF |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Brain & Behavior Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep quality measured by wrist actigraphy and daily sleep diaries | Averages of: 2-week pre-treatment baseline; last 2 weeks of treatment; 2-week long-term follow-up occuring 3-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of yoga program as measured by a 2-item Yoga Evaluation Form (End) and a 2-item Yoga Evaluation Form (Followup) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Potential subjects are ineligible if pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica J Noggle Taylor, PhD | Emory University | Principal Investigator |
| Sat Bir S Khalsa, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02116 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000092862 | Psychological Well-Being |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Averages over duration of intervention (8 weeks total) |
| Accrual rate calculated from recruitment and consent information | 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 | 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) | 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 | 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) | 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) | 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) | 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) | 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 | Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |