Department of Human Sciences, Guglielmo Marconi University, Rome, Italy.
Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
BMC Psychol. 2024 Jun 10;12(1):340. doi: 10.1186/s40359-024-01827-1.
Sleep is vital for maintaining individuals' physical and mental health and is particularly challenged during pregnancy. More than 70% of women during the gestational period report insomnia symptoms. Sleep dysfunction in the peripartum increases the risk for a cascade of negative health outcomes during late pregnancy, birth, and postpartum. While psychological interventions are considered the first line treatment for sleep difficulties, they are still scarcely offered during pregnancy and there is a lack of longitudinal research combining psychological and physiological indices.
The present protocol outlines a randomized controlled trial aimed at testing the long-term effectiveness of an automatized digitalized psychoeducational intervention for insomnia for expectant mothers complaining insomnia symptoms without comorbidity. Outcomes include physiological, hormonal, and subjective indices of maternal psychopathology, stress, and emotional processes, and sleep and wellbeing of the family system. The trial is part of a longitudinal study evaluating expectant mothers from early pregnancy (within the 15th gestational week) to 6-months postpartum through 6 observational phases: baseline (BSL), 6- and 12-weeks from BSL (FU1-FU2), 2-to-4 weeks after delivery (FU3), and 3- and 6-months after delivery (FU4-5). We plan to recruit 38 women without sleep difficulties (Group A) and 76 women with sleep difficulties (Group B). Group B will be randomly assigned to digital psychological control intervention (B1) or experimental psychoeducational intervention targeting insomnia (B2). At 3 time points, an ecological-momentary-assessment (EMA) design will be used to collect data on sleep and emotions (diaries), sleep-wake parameters (actigraphy) and stress reactivity (salivary cortisol). We will also test the DNA methylation of genes involved in the stress response as biomarkers of prenatal poor sleep. Information on partner's insomnia symptoms and new-borns' sleep will be collected at each stage.
The proposed protocol aims at testing an easily accessible evidence-based psychoeducational intervention for expectant mothers to help them improving sleep, health, and wellbeing in the peripartum. The results could improve the understanding and management of sleep difficulties and peripartum depression.
The study protocol has been registered on 22 April 2024 with ClinicalTrials.gov Protocol Registration and Results System (PRS), ID: NCT06379074.
April 23, 2024.
睡眠对于维持个体的身心健康至关重要，而在怀孕期间尤其具有挑战性。超过 70%的孕妇报告存在失眠症状。围产期的睡眠功能障碍会增加孕妇在妊娠晚期、分娩和产后出现一系列负面健康后果的风险。虽然心理干预被认为是治疗睡眠困难的首选方法，但在怀孕期间仍然很少提供，并且缺乏结合心理和生理指标的纵向研究。
本方案概述了一项随机对照试验，旨在测试针对有失眠症状但无合并症的孕妇的自动化数字化心理教育干预对失眠的长期有效性。结果包括孕产妇精神病理学、压力和情绪过程以及家庭系统的睡眠和幸福感的生理、激素和主观指标。该试验是一项纵向研究的一部分，该研究从早期妊娠（第 15 孕周内）到产后 6 个月通过 6 个观察阶段评估孕妇：基线（BSL）、BSL 后 6 周和 12 周（FU1-FU2）、分娩后 2-4 周（FU3）以及分娩后 3 个月和 6 个月（FU4-5）。我们计划招募 38 名无睡眠困难的孕妇（A 组）和 76 名有睡眠困难的孕妇（B 组）。B 组将随机分配到数字心理控制干预（B1）或针对失眠的实验心理教育干预（B2）。在 3 个时间点，将使用生态瞬时评估（EMA）设计收集睡眠和情绪（日记）、睡眠-觉醒参数（活动记录仪）和应激反应（唾液皮质醇）的数据。我们还将测试涉及应激反应的基因的 DNA 甲基化作为产前睡眠不良的生物标志物。每个阶段都会收集有关伴侣失眠症状和新生儿睡眠的信息。
拟议的方案旨在测试一种易于获取的基于证据的心理教育干预措施，以帮助孕妇改善围产期的睡眠、健康和幸福感。结果可以提高对睡眠困难和围产期抑郁的理解和管理。
该研究方案于 2024 年 4 月 22 日在 ClinicalTrials.gov 注册和结果系统（PRS）上注册，ID：NCT06379074。
2024 年 4 月 23 日。
