一项可扩展的认知行为方案，以促进孕期和产后期间的健康睡眠：一项随机对照试验的方案（SEED 项目）。
A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project).
机构信息
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Victoria, 3800, Australia.
Centre for Women's Mental Health, Department of Psychiatry, University of Melbourne, Royal Women's Hospital, Melbourne, Victoria, Australia.
出版信息
BMC Pregnancy Childbirth. 2019 Jul 22;19(1):254. doi: 10.1186/s12884-019-2390-8.
BACKGROUND
Poor sleep, including symptoms of insomnia are common during pregnancy and postpartum periods. Poor sleep during the perinatal period is linked to impaired daytime functioning, mood disturbance, and risk for chronic insomnia. Cognitive behavioural therapy (CBT) is consistently shown to be efficacious in treating insomnia, but it is largely inaccessible to new mothers, and surprisingly, not part of current perinatal care. This study aims to evaluate the feasibility and efficacy of a scalable CBT-based intervention for better sleep quality.
METHODS
In this single-blind randomised controlled trial, eligible nulliparous women are randomised in a 1:1 ratio to either the intervention (CBT) or active control (healthy diet) condition. The interventions are provided from the third trimester till 6 months postpartum. The primary outcome is maternal sleep quality and secondary outcomes are maternal sleep-related impairment, mood, health-related quality of life, relationship satisfaction, and mother-infant-relationship, all assessed using validated instruments at 30- (baseline) and 35 weeks gestation (pregnancy endpoint), and 1.5, 3, and 6 months (postpartum endpoint) after childbirth, with follow-up assessments conducted at 1-year and 2-year postpartum.
DISCUSSION
This study has the potential to address the need for an evidence-based, non-pharmacological sleep intervention tailored for the pregnancy and postpartum periods. The intervention is designed to maximise reach and minimise cost, with the potential to scale up and incorporate in routine perinatal care. With outcomes measured at 8 time points, from the third trimester of pregnancy to 2-year postpartum, this study has the potential to examine both short- and long-term impact on maternal sleep and wellbeing.
TRIAL REGISTRATION
ACTRN12616001462471 ; retrospectively registered on 19/10/2016.
背景
妊娠和产后期间，睡眠质量差（包括失眠症状）很常见。围产期睡眠质量差与白天功能受损、情绪障碍以及慢性失眠风险相关。认知行为疗法（CBT）在治疗失眠方面已被证实具有疗效，但它对新妈妈来说基本难以获得，而且令人惊讶的是，它也不属于当前围产期护理的一部分。本研究旨在评估一种基于 CBT 的可扩展干预措施改善睡眠质量的可行性和疗效。
方法
在这项单盲随机对照试验中，合格的初产妇以 1:1 的比例随机分配至干预组（CBT）或对照组（健康饮食）。干预措施从妊娠晚期持续到产后 6 个月。主要结局是母亲的睡眠质量，次要结局是母亲的睡眠相关障碍、情绪、健康相关生活质量、关系满意度和母婴关系，所有这些都使用经过验证的工具在 30-（基线）和 35 周妊娠（妊娠终点）以及产后 1.5、3 和 6 个月（产后终点）进行评估，并在产后 1 年和 2 年进行随访评估。
讨论
本研究有可能满足对基于证据的、针对妊娠和产后期间的非药物性睡眠干预措施的需求。该干预措施旨在最大限度地扩大覆盖范围并降低成本，具有扩大规模并纳入常规围产期护理的潜力。通过 8 个时间点的结果测量，从妊娠晚期到产后 2 年，本研究有可能检查对母亲睡眠和健康的短期和长期影响。
试验注册
ACTRN12616001462471；2016 年 10 月 19 日回顾性注册。
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