目的:失眠症状在围产期很常见,并与不良结局有关。这项单盲三臂随机对照试验研究了两种针对不同机制的干预措施是否可以预防产后失眠。
方法:参与者为妊娠26-32周,失眠症严重程度指数(ISI)评分≥8分的未产女性,在澳大利亚招募,随机分为1:1:1:1:(a)旨在支持婴儿睡眠并减少产妇睡眠中断的反应摇篮,直至产后6个月(RB),(b)在怀孕和产后期间提供的治疗师辅助的失眠症认知行为疗法(CBT-I),或(c)睡眠卫生手册(对照;CTRL)。结果在基线(T1)进行评估,妊娠35-36周(T2),以及产后2、6和12个月(T3-T5)。主要结果是平均T3-T5的ISI评分。主要分析是控制基线结果的回归分析。
结果:127名参与者(年龄M±SD=32.62±3.49)被随机分组(RB=44,CBT-I=42,CTRL=41)。这两种干预措施都是可行且广为接受的,报道的相关不良事件很少。与CTRL相比,对于CBT-I(p=.014,效应大小[ES]=0.56,中等),而不是RB(p=.270,ES=0.25,小),整个T3-T5的平均ISI较低。关于母亲失眠诊断的探索性发现,睡眠障碍,睡眠相关障碍,关于睡眠的信念和态度,抑郁症,焦虑,还介绍了婴儿睡眠结果。
结论:CBT-I而不是RB减少了产前失眠(非常大的效果)并预防了产后失眠(中等效果)。需要进一步的研究来检查CBT-I和RB对其他结果的影响,例如与睡眠相关的健康。产后抑郁症,和产妇产后睡眠时间。
OBJECTIVE: Insomnia symptoms are common during the perinatal period and are linked to adverse outcomes. This single-blind three-arm randomized-controlled
trial examined whether two interventions targeting different mechanisms prevent postpartum insomnia.
METHODS: Participants were nulliparous females 26-32 weeks gestation with Insomnia Severity Index (ISI) scores ≥ 8, recruited in Australia and randomized 1:1:1 to: (1) a responsive bassinet (RB) designed to support infant sleep and reduce maternal sleep disruption until 6 months postpartum, (2) therapist-assisted cognitive behavioral therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (3) a sleep hygiene booklet (control; CTRL). Outcomes were assessed at baseline (T1), 35-36 weeks gestation (T2), and 2, 6, and 12 months postpartum (T3-T5). The primary outcome was ISI scores averaged T3-T5. Primary analyses were regressions controlling for baseline outcomes.
RESULTS: One hundred and twenty-seven participants (age M ± SD = 32.62 ± 3.49) were randomized (RB = 44, CBT-I = 42, CTRL = 41). Both interventions were feasible and well-accepted, with few related adverse events reported. Compared to CTRL, the average ISI across T3-T5 was lower for CBT-I (p = .014, effect size [ES] = 0.56, medium) but not RB (p = .270, ES = 0.25, small). Exploratory findings on maternal insomnia diagnosis, sleep disturbance, sleep-related impairment, beliefs and attitudes about sleep, depression, anxiety, as well as infant sleep outcomes were also presented.
CONCLUSIONS: CBT-I but not RB reduced prenatal insomnia (very large effect) and prevented postpartum insomnia (medium effect). Further research is needed to examine the effects of both CBT-I and RB on other outcomes such as sleep-related well-being, postpartum depression, and maternal postpartum sleep duration.
BACKGROUND: The
Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers. https://www.anzctr.org.au/
Trial/Registration/TrialReview.aspx?id=377927, Australian New Zealand Clinical Trials Registry: ACTRN12619001166167.