Session content for education only control group.

Sleep deficiency is common during pregnancy, with consequences for maternal and fetal health. This pilot study assessed the efficacy, feasibility, and acceptability of a six-week, online, mindfulness-based intervention (OPTIMISM) in pregnant women with sleep deficiency. Participants were randomized to either mindfulness (self-directed learning modules about mindfulness meditation, sleep challenges in pregnancy, and behavioral strategies) or education-only control conditions. Participants completed surveys and wore an actigraph with daily sleep diaries for 8 days at baseline and post-intervention. The primary outcome was sleep quality. Secondary outcomes included actigraphy, sleep-related impairment, sleep disturbance, fatigue, depression, anxiety, postnatal depressive symptoms, well-being, and quality of life. Exploratory outcomes included feasibility, acceptability, self-management, and behavior change. Efficacy was estimated with analysis of covariance, comparing mean post-test scores corrected for baseline. Of the 351 women screened, 163 were eligible, 64 enrolled, and 59 were randomized. 45 participants (OPTIMISM, 23; control, 22) completed post-intervention assessments and were included in the analysis. The mean satisfaction with the OPTIMISM was higher than the control group (OPTIMISM, 4.1; control, 3.8). The mean sleep quality score was significantly improved in the OPTIMISM group compared to that in the control group after adjusting for baseline score (OPTIMISM, 5.4; control, 7.6; p =.008; partial h2 =.157). There were similar improvements in sleep-related impairment, sleep disturbance, fatigue, and depressive symptoms, but no differences in other outcomes. Findings suggest that OPTIMISM improves subjective sleep quality and psychological distress, including fatigue, depression, and anxiety during pregnancy and should be tested in larger trials with longitudinal follow-up.Trial registration: ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019.睡眠不足在妊娠期极为常见，可对母体及胎儿健康产生不良影响。本试点研究针对存在睡眠不足的妊娠期女性，评估了为期六周的在线正念干预（mindfulness-based intervention）项目OPTIMISM的有效性、可行性与可接受性。受试者被随机分配至正念干预组（包含正念冥想、妊娠期睡眠挑战及行为策略的自主学习模块）或纯健康教育对照组。受试者在基线与干预后阶段分别完成问卷调研，并连续8天佩戴体动记录仪（actigraph）并填写每日睡眠日志。 本研究的主要结局指标为睡眠质量。次要结局指标包括体动记录仪监测结果、睡眠相关损害、睡眠障碍、疲劳、抑郁、焦虑、产后抑郁症状、幸福感与生活质量。探索性结局指标则涵盖可行性、可接受性、自我管理与行为改变情况。本研究采用协方差分析对干预后平均得分进行基线校正后比较，以此评估干预效果。在351名接受筛查的女性中，163名符合入组标准，64名完成入组，最终59名被随机分组。其中45名受试者（OPTIMISM干预组23名，对照组22名）完成了干预后评估并被纳入最终分析。 受试者对OPTIMISM项目的平均满意度高于对照组（干预组4.1分，对照组3.8分）。校正基线得分后，干预组的平均睡眠质量得分较对照组有显著改善（干预组5.4分，对照组7.6分；p=0.008，偏η²=0.157）。睡眠相关损害、睡眠障碍、疲劳及抑郁症状也出现了类似的改善，但其余结局指标未观察到组间差异。 研究结果表明，OPTIMISM项目可改善妊娠期女性的主观睡眠质量与心理困扰（包括疲劳、抑郁与焦虑），后续应开展含纵向随访的大规模临床试验对其进行验证。 试验注册：ClinicalTrials.gov，编号NCT04016428，于2019年7月11日完成注册。