Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial
Pilot and Feasibility Studies September 20, 2020 Ira Kantrowitz-Gordon, Susan M. McCurry, Carol A. Landis et al.
This ongoing randomized controlled trial tests the feasibility and estimates the efficacy of a 6-week online mindfulness meditation intervention, combined with cognitive-behavioral therapy for insomnia (CBT-I), to help pregnant women in remission from depression self-manage insomnia. Fifty pregnant women between 12 and 28 weeks gestation will be randomly assigned to a mindfulness or education-only control group. Feasibility outcomes include recruitment, retention, adherence, and acceptability; the primary clinical outcome is sleep quality measured by the Pittsburgh Sleep Quality Index. Secondary outcomes include actigraphy and diary-based sleep measures, mood, and self-management factors. Results will inform a larger efficacy trial.