Feasibility and Acceptability of Mindfulness-based Stress Reduction and Prenatal Sleep Classes for Poor Prenatal Sleep Quality: Pilot Randomized Controlled Trial

• Published in: Behavioral sleep medicine 2024-09, Vol.22 (5), p.739-753
• Main Authors: Felder, J. N., Mirchandaney, R., Manber, R., Cuneo, J., Krystal, A., Solomon, N., Janette, S., Zhang, L., Moran, P, Mashash, M., Epel, E, Hecht, F. M
• Format: Article
• Language: English
• Subjects: Adult; Client satisfaction; Clinical trials; Cognitive behavioral therapy; Cognitive-behavioral factors; Efficacy; Feasibility; Feasibility Studies; Female; Humans; Insomnia; Mindfulness; Mindfulness - methods; Patient Acceptance of Health Care - statistics & numerical data; Perinatal period; Pilot Projects; Pregnancy; Pregnancy Complications - therapy; Prenatal care; Prenatal Care - methods; Public health; Sleep; Sleep Initiation and Maintenance Disorders - physiopathology; Sleep Initiation and Maintenance Disorders - therapy; Sleep Quality; Stress management; Stress, Psychological - therapy; Women
• ISSN: 1540-2002; 1540-2010; 1540-2010
• DOI: 10.1080/15402002.2024.2359415

The main objectives of the current paper were to examine the feasibility, acceptability, and adherence of a remotely delivered intervention consisting of mindfulness-based stress reduction plus prenatal sleep classes (MBSR+PS) compared with treatment as usual (TAU). In this pilot randomized controlled trial, 52 pregnant women with poor sleep quality were randomized to MBSR+PS or TAU. MBSR was delivered through eight weekly 2.5-hour sessions, and PS was delivered through eight weekly 30-minute sessions. PS content drew material from cognitive behavioral therapy for insomnia tailored for the perinatal period and from a mindfulness- and acceptance-based lens. Participants completed endpoint measures 10-12 weeks after randomization. We surpassed all acceptability targets, including the percentage of eligible participants willing to be randomized (96%), percentage of participants who initiated treatment (88%), and satisfaction scores (Client Satisfaction Questionnaire-8 score M = 28.04, SD = 3.6). We surpassed all feasibility targets, including our enrollment target, retention rate (92%), and measure completion (96%). Finally, we surpassed adherence targets, including MBSR and PS session attendance (≥80%). Though sleep outcomes were exploratory, increases in sleep efficiency were greater in the MBSR+PS group relative to TAU (SMD=.68). Patient-reported poor sleep quality during pregnancy has high public health significance because it is common, consequential, and under-treated. The current feasibility and acceptability data for using remotely delivered MBSR and PS to improve prenatal sleep quality are encouraging and warranting future research that is sufficiently powered and designed to provide efficacy data. In addition, exploratory sleep outcomes offer preliminary evidence that this sleep program may improve sleep efficiency during pregnancy.