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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
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
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)
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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