Online prenatal trial in mindfulness sleep management (OPTIMISM) (treatment of insomnia in pregnancy)

Description

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.