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: 8662566
• 负责人: RACHEL MANBER
• 金额: $ 53.71万
• 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/8662566
• 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; 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.

描述(由申请人提供)：与NINR战略计划一致，以确定将减少少数群体和服务不足人群中产妇和生殖健康不良的长期不利后果的战略，该提案旨在评估在经济、教育、种族和民族多样性的孕妇样本中基于初级保健的孕产妇失眠障碍(MID)干预措施。MID包括怀孕和产后失眠，与母亲和她的家人的不良后果有关。这些风险包括早产风险增加、小于胎龄婴儿的出生、剖腹产、母婴依恋不良、婚姻关系恶化以及围产期抑郁风险增加。失眠的认知行为疗法(CBTI)是一种有效的失眠治疗方法，即使在个人无法控制的因素干扰睡眠的情况下也是如此。CBTI对产后失眠有效，尽管夜间需要照顾婴儿导致睡眠中断。TIPS(婴儿和父母睡眠小贴士)是一项为期两节的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。为了最大限度地影响公共卫生，改善获得机会，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。这将是第一个测试CBTI治疗MID疗效的研究。这项研究的主要结果是母体睡眠和婴儿睡眠，这项研究经过了优化设计和足够的动力。次要结果是妊娠结果(小于胎龄的婴儿的比例)、母婴依恋及其生物标志物催产素，以及母亲的幸福感(抑郁症状严重程度和生活质量)。这项研究的目的是：(1)评估CBTI+TIPS在a)孕期母体睡眠和b)产后母婴睡眠方面的有效性；(2)评估CBTI+TIPS在睡眠以外的测量方面的有效性，包括小于胎龄儿的出生数量，b)母婴依恋(基于与NCAST的亲子互动观察)，c)催产素水平，d)母亲抑郁症状严重程度，以及(E)母亲的生活质量。