Online prenatal trial in mindfulness sleep management (OPTIMISM)

This is a two-arm, parallel-group randomized controlled trial. A total of 45 pregnant women between 12 and 28 weeks gestation were recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants completed six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures included study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure was sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures included sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments occurred at baseline and post-intervention; an additional acceptability survey was completed 4 weeks postpartum.

Methods
Study survey data were collected and managed using Research Electronic Data Capture (REDCap). Objective sleep data were collected using a combination of daily sleep diaries and nighttime actigraphy with an Actiwatch Spectrum Plus (Philips Respironics, Murrysville, PA). Participants were asked to wear the actigraph and keep sleep diaries for 8 days at baseline and post-intervention. Actigraphy-measured sleep variables included total sleep time (TST), defined as the number of minutes of all time spent asleep; sleep efficiency (SE), a measure of sleep quality calculated as the ratio of TST divided by total time in bed ×100, with values closer to 100 meaning more efficient (better) sleep; sleep onset latency (SOL), defined as the number of minutes from getting into bed to falling asleep; total wake time (TWT), defined as the total number of minutes spent awake during the rest period; and wake after sleep onset (WASO), defined as the number of minutes awake between time falling asleep and wake time.