Verma Sumedha, Rajaratnam Shantha M W, Davey Margot, Wiley Joshua F, Bei Bei
Faculty of Medicine, Nursing and Health Sciences, School of Psychological Sciences, The Turner Institute for Brain and Mental Health, Monash University, Clayton, VIC, Australia.
Melbourne Children's Sleep Unit, Monash Medical Centre, Clayton South, VIC, Australia.
Front Glob Womens Health. 2021 Jan 15;1:591677. doi: 10.3389/fgwh.2020.591677. eCollection 2020.
Symptoms of insomnia are common in new mothers and have been associated with a range of negative maternal and child outcomes. Despite this, interventions to improve maternal postpartum sleep remain scarce. Cognitive Behavioural Therapy (CBT) and Light Dark Therapy (LDT) represent two promising interventions for insomnia symptoms and associated daytime consequences such as fatigue. This randomised controlled trial examines whether CBT and LDT improve maternal insomnia symptoms as the primary outcome and maternal sleep disturbance, mood, fatigue, and sleepiness as secondary outcomes. This protocol paper outlines the development, design, and implementation of the trial. Participants are an Australian community-sample of 90 first-time mothers who are 4-12 months postpartum with self-reported symptoms of insomnia (Insomnia Severity Index scores ≥ 8). Exclusion criteria include current severe sleep/psychiatric disorders, unsettled infant sleep behaviour, sleep-affecting medication use, and photosensitivity. Eligible women are randomised into a CBT (strategies targeting sleep, worries, fatigue, and relaxation), LDT, or a treatment-as-usual control condition. Interventions are therapist-assisted and personalised through two telephone calls and include a series of automated intervention emails delivered over 6 weeks. Primary and secondary outcomes are assessed at four time points: baseline, intervention mid-point, post-intervention, and 1-month post-intervention. If found effective, these interventions could represent efficacious, safe, and inexpensive treatments for improving postpartum insomnia and mitigate its negative impact on maternal well-being. Interventions tested are highly scalable and can be integrated into postpartum care and made available to the broader community. Accessible at: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000842268.
失眠症状在初为人母的女性中很常见，并且与一系列负面的母婴结局有关。尽管如此，改善产妇产后睡眠的干预措施仍然很少。认知行为疗法（CBT）和明暗疗法（LDT）是针对失眠症状以及诸如疲劳等相关日间后果的两种有前景的干预措施。这项随机对照试验检验CBT和LDT是否能改善产妇失眠症状这一主要结局，以及产妇睡眠障碍、情绪、疲劳和嗜睡等次要结局。本方案文件概述了该试验的开展、设计和实施情况。参与者是来自澳大利亚社区的90名初产妇样本，她们产后4至12个月，有自我报告的失眠症状（失眠严重程度指数得分≥8）。排除标准包括当前严重的睡眠/精神疾病、婴儿睡眠行为不稳定、使用影响睡眠的药物以及光敏性。符合条件的女性被随机分为CBT组（针对睡眠、担忧、疲劳和放松的策略）、LDT组或常规治疗对照组。干预措施由治疗师协助并通过两次电话进行个性化定制，还包括在6周内发送的一系列自动干预电子邮件。主要和次要结局在四个时间点进行评估：基线、干预中点、干预后和干预后1个月。如果被证明有效，这些干预措施可能代表改善产后失眠并减轻其对产妇幸福感负面影响的有效、安全且廉价的治疗方法。所测试的干预措施具有高度可扩展性，可以整合到产后护理中并提供给更广泛的社区。可访问：https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000842268。
