The effectiveness of non-pharmacological treatment for perinatal insomnia

非药物治疗围产期失眠的有效性

• 批准号: 8341554
• 负责人: RACHEL MANBER
• 金额: $ 58.71万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-03 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8341554
• 关键词: Acute; Adopted; Aftercare; Age; Arousal; Behavior; Biological Markers; Birth; British; Caring; Clinic; Cognition; Cognitive Therapy; Communities; Consensus; Discipline of obstetrics; Educational Intervention; Effectiveness; Family; Health; Improve Access; Individual; Infant; Intervention; Lead; Low income; Marital Relationships; Maternal Age; Maternal Health; Measures; Medical; Mental Depression; Methods; Minority; Mothers; Nurses; Oxytocin; Parent-Child Relations; Parents; Patients; Perinatal; Postpartum Period; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Primary Health Care; Psychotherapy; Public Health; Quality of life; Relative (related person); Reproductive Health; Research; Risk; Sampling; Services; Severities; Sleep; Sleeplessness; Small for Gestational Age Infant; Stigmata; Strategic Planning; Target Populations; Telephone; Testing; Time; Training; Transportation; Underserved Population; United States Department of Veterans Affairs; United States National Institutes of Health; Weight; Woman; active control; adverse outcome; awake; base; chronic pain; depressive symptoms; design; effective therapy; efficacy testing; evidence base; flexibility; hypnotic; improved; novel; primary outcome; programs; secondary outcome; social stigma

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. PUBLIC HEALTH RELEVANCE: The reduction of long-term adverse consequences of poor maternal and reproductive health in minorities and underserved populations is a high priority in NINR. Poor sleep is one such health issue, associated with adverse consequences to the mother and her family, including increased risk for preterm birth, infants small for gestational age, cesarean birth, poor maternal infant attachment, worsening of the marital relationship, and increased risk for perinatal depression. We propose to test the effectiveness of a culturally sensitive primary care based, nurse-delivered, non-pharmacological intervention to improve maternal sleep during pregnancy and the postpartum.

描述（由申请人提供）：与NINR战略计划一致，以确定减少少数民族和服务不足人群中孕产妇和生殖健康不良的长期不良后果的战略，该提案旨在评估基于初级保健的干预措施，用于在经济，教育，种族和种族多样化的孕妇样本中治疗孕产妇失眠症（MID）。MID包括怀孕期间和产后的失眠，与母亲及其家人的不良后果有关。这些包括早产、小于胎龄婴儿出生、剖腹产、母婴依恋不良、婚姻关系恶化以及围产期抑郁症风险增加。失眠的认知行为疗法（CBTI）是一种有效的治疗失眠的方法，即使是在个人控制之外的因素干扰睡眠的情况下。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）是一个两个会话，护士管理的教育干预，旨在优化婴儿睡眠。我们建议评估综合CBTI+TIPS治疗的疗效和有效性。为了最大限度地扩大对公共卫生的影响，改善获得治疗的机会，减少治疗障碍（耻辱和交通问题），将由社区产科诊所的护士提供治疗，妇女在怀孕期间接受护理，直到产后六周。这将是第一项测试CBTI治疗MID疗效的研究。研究的主要结果是产妇睡眠和婴儿睡眠，这是最佳设计和足够的动力。次要结局（我们无法估计功效或预期功效不足）是妊娠结局（小于胎龄婴儿的比例）、母婴依恋及其生物学标志物催产素和母亲幸福感（抑郁症状严重程度和生活质量）。本研究的目的是：（1）评价CBTI+TIPS在a）妊娠期母亲睡眠和B）产后母婴睡眠方面的疗效;（2）评估CBTI+TIPS对睡眠以外的测量的有效性，包括出生小于胎龄儿的数量，B）母婴依恋（基于与NCAST的亲子互动的观察），c）催产素水平，d）母亲抑郁症状严重程度，和（e）母亲生活质量。 公共卫生关系：减少少数民族和得不到充分服务的人口的产妇保健和生殖保健不良的长期不利后果是国家营养研究所的一个高度优先事项。睡眠不佳是这样一个健康问题，与母亲及其家庭的不良后果有关，包括早产风险增加，婴儿小于胎龄，剖腹产，母婴依恋不良，婚姻关系恶化，以及围产期抑郁症风险增加。我们建议测试的有效性，一个文化敏感的初级保健为基础的，护士提供的，非药物干预，以改善产妇在怀孕期间和产后的睡眠。