The effectiveness of non-pharmacological treatment for perinatal insomnia

描述（由申请人提供）：与NINR战略计划一致，确定将减少少数民族和服务不足人群中孕产妇和生殖健康状况不佳的长期不良后果的战略，本提案旨在评估基于初级保健的孕产妇失眠症（MID）干预措施在经济，教育，种族和民族不同的孕妇样本中。MID包括怀孕期间和产后失眠，与母亲及其家人的不良后果有关。其中包括早产风险增加、小于胎龄婴儿出生、剖宫产、母婴依恋不良、婚姻关系恶化以及围产期抑郁症风险增加。认知行为治疗失眠（CBTI）是一种有效的治疗失眠的方法，即使个人控制之外的因素干扰了睡眠。CBTI对产后失眠有效，尽管夜间需要照顾婴儿会导致睡眠中断。TIPS（婴儿和父母睡眠提示）是一个两节，护士管理的教育干预，旨在优化婴儿睡眠。我们建议评估CBTI+TIPS综合治疗的疗效和有效性。为了最大限度地提高对公共卫生的影响，改善获取途径，减少治疗障碍（污名化和运输问题），治疗将由社区产科诊所的护士提供，妇女在怀孕期间直至产后六周接受护理。这将是首个测试CBTI治疗MID疗效的研究。该研究的主要结果是母亲的睡眠和婴儿的睡眠，该研究是经过优化设计和充分支持的。次要结局是妊娠结局（小于胎龄的婴儿比例）、母婴依恋及其生物标志物、催产素和母亲的幸福感（抑郁症状的严重程度和生活质量）。本研究的目的是：(1)评估CBTI+TIPS在a)孕期孕产妇睡眠和b)产后母婴睡眠方面的疗效；（2)评估CBTI+TIPS在睡眠以外的指标上的有效性，包括小于胎龄出生的婴儿数量，b)母婴依恋（基于对NCAST亲子互动的观察），c）催产素水平，d)母亲抑郁症状严重程度，以及(e)母亲生活质量。

DESCRIPTION (provided by applicant): Consistent with the NINR strategic plan to identify strategies that will reduce the long-term adverse consequences of poor maternal and reproductive health in minorities and underserved populations, this proposal aims to evaluate a primary care based intervention for maternal insomnia disorder (MID) among economically, educationally, racially, and ethnically diverse samples of pregnant women. MID, which encompasses insomnia during pregnancy and postpartum, is associated with adverse consequences to the mother and her family. These include increased risk for preterm birth, births of infants small for gestational age, cesarean birth, poor maternal infant attachment, worsening of the marital relationship, and increased risk for perinatal depression. Cognitive Behavioral Therapy for Insomnia (CBTI) is an effective treatment for insomnia even when factors outside of an individual's control interfere with sleep. CBTI is effective for postpartum insomnia, despite sleep disruption caused by the need to attend to an infant at night. TIPS (Tips for Infant and Parent Sleep) is a two- session, nurse-administered educational intervention aimed at optimizing infant sleep. We propose to evaluate the efficacy and effectiveness of an integrated CBTI+TIPS treatment. To maximize the public health impact, improve access, and reduce treatment barriers (stigma and transportation issues), treatment will be delivered by nurses in community obstetrical clinics, where women receive care during their pregnancy until six weeks postpartum. This will be the first study to test the efficacy of CBTI for the treatment o MID. Primary outcomes, for which the study is optimally designed and sufficiently powered, are maternal sleep and infant sleep. Secondary outcomes, for which we are either unable to estimate power or expect to be under powered, are pregnancy outcomes (proportion of infants who are small for gestational age), maternal-infant attachment and its biological marker, oxytocin, and maternal wellbeing (depressive symptom severity and quality of life). The Aims of this research are to: (1) evaluate the efficacy of CBTI+TIPS in terms of a) maternal sleep during pregnancy and b) maternal and infant sleep during the postpartum; (2) evaluate the effectiveness of CBTI+TIPS on measures beyond sleep, including number of infants born small for gestational age, b) maternal-infant attachment (based on observations of a parent-child interactions with the NCAST), c) oxytocin levels, d) maternal depressive symptom severity, and (e) maternal quality of life.