Data from: 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.