Kantrowitz-Gordon Ira, McCurry Susan M, Landis Carol A, Lee Rachel, Wi Dahee
Child, Family, and Population Health Nursing, University of Washington, Box 357262, Seattle, WA 98195 USA.
Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195 USA.
Pilot Feasibility Stud. 2020 Sep 14;6:128. doi: 10.1186/s40814-020-00675-1. eCollection 2020.
Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia.
This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be 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 will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include 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 will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include 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 will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis.
This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial.
ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.
睡眠不足影响大多数孕妇，对其日常功能、情绪以及妊娠和分娩结局有重大影响。这项正在进行的研究将两种改善睡眠和情绪的循证策略——正念冥想和失眠认知行为疗法（CBT-I）——以一种独特的在线形式相结合，以满足孕妇的特殊需求。本研究的目的是测试这种新颖的为期6周的在线正念冥想干预措施帮助处于抑郁缓解期的孕妇自我管理失眠的可行性，并评估其效果。
这是一项双臂、平行组随机对照试验。将从社区招募总共50名孕周在12至28周之间的孕妇，并以1:1的比例随机分配到正念组或仅接受教育的对照组。在研究期间，所有参与者将完成六个每周一次的在线模块、每日睡眠日记，并可选择参与特定治疗的在线讨论论坛。可行性结果指标将包括研究招募、保留率、干预依从性（完成的在线模块数量、每周冥想天数）和干预可接受性（8项问卷）。主要临床结果指标将是用匹兹堡睡眠质量指数测量的睡眠质量。次要结果指标将包括用活动记录仪和日记测量的睡眠（睡眠效率、总睡眠时间、总清醒时间）、患者报告结局测量信息系统（PROMIS）指标（疲劳、与睡眠相关的损害、睡眠障碍）；情绪（抑郁、焦虑、积极情绪、生活质量）；以及自我管理和行为改变（潜在自我效能感、自我调节、对睡眠问题的接受度和特质正念）。评估将在基线和干预后进行；产后4周将完成一项额外的可接受性调查。分析将检查从基线到干预后结果变化分数的组内差异。开放式反馈将使用定性内容分析进行分析。
本研究在采用自我管理研究设计和方法解决孕期睡眠问题方面具有创新性，这些方法对于大量孕妇来说是可获取且具有成本效益的。本研究的结果将为在更大规模的随机对照试验中改进干预措施和测试其效果提供依据。
ClinicalTrials.gov，NCT04016428。于2019年7月11日注册。2019年7月26日注册了更新版本。
