1/2-Preventing Depressive Relapse in Pregnant Women with Recurrent Depression

1/2-预防复发性抑郁症孕妇的抑郁症复发

• 批准号: 9920204
• 负责人: Sona Dimidjian
• 金额: $ 44.69万
• 依托单位: UNIVERSITY OF COLORADO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-23 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9920204
• 关键词: Address; Adult; Algorithms; Antidepressive Agents; Attenuated; Caring; Characteristics; Child; Child Development; Clinical; Clinical assessments; Cognitive; Colorado; Community Practice; Compassion; Decision Making; Effectiveness; Enrollment; Exposure to; General Hospitals; Grant; Health Personnel; Intervention; Investigation; Maintenance; Major Depressive Disorder; Massachusetts; Mediating; Mental Depression; Mental Health; Monitor; Mood Disorders; Morbidity - disease rate; Outcome; Pharmacological Treatment; Populations at Risk; Postpartum Period; Pregnancy; Pregnant Women; Prevention; Provider; Randomized; Recording of previous events; Recurrence; Relapse; Relative Risks; Research Project Grants; Risk; Role; Selection for Treatments; Site; Symptoms; Testing; Time; Universities; Woman; Work; aged; base; care providers; clinical decision-making; community setting; data management; depressive symptoms; digital; disorder later incidence prevention; interest; mindfulness; mindfulness based cognitive therapy; practice setting; pragmatic trial; preference; prenatal exposure; prevent; prospective; randomized trial; recruit; recurrent depression; reduce symptoms; relapse prediction; relapse risk; reproductive; standard of care; theories; tool; treatment as usual; treatment guidelines; trial comparing

PROJECT ABSTRACT Depressive relapse during pregnancy is highly prevalent particularly among women with recurrent depression. Maternal psychiatric morbidity associated with depressive relapse during pregnancy is of concern as is the impact of untreated mood disorder during pregnancy and the postpartum period on child development. While maintenance antidepressant treatment is the standard of care for women with recurrent depression, concerns exist regarding known and unknown effects of fetal exposure to these agents; understandably, many pregnant women and their providers seek non-pharmacologic alternatives to pharmacologic treatment during pregnancy. Mindfulness-based cognitive therapy (MBCT) is efficacious in the prevention of depressive relapse among pregnant women as compared to usual care and is scalable using digital delivery. We propose a pragmatic effectiveness trial comparing MBCT to usual care (UC) among euthymic pregnant women (N=500) with recurrent depression treated with maintenance antidepressants. The study will be conducted at the University of Colorado Boulder (UCB; PI Dimidjian) and Massachusetts General Hospital (MGH; PI Cohen) using the Collaborative RO1 mechanism. This grant mechanism is justified given the unique expertise brought by each site to the proposed investigation. Specifically, the UCB site provides expertise in pragmatic randomized trials and MBCT for pregnant women, and the MGH site provides expertise in prospective monitoring of pregnant women with mood disorders. We will address three primary aims: 1) to examine the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC; 2) to examine the risk for depressive relapse between women who are randomized to MBCT who discontinue antidepressant treatment and those randomized to UC who discontinue antidepressant treatment, and to apply a treatment selection algorithm to ask what works for whom with respect to MBCT versus antidepressant maintenance; and 3) to examine the extent to which digital MBCT engages key putative targets. Systematic investigation of interventions that can attenuate risk for depressive relapse during pregnancy particularly in “at risk” populations minimizes the morbidity of recurrent depression during critical times in the lives of reproductive aged women.

项目摘要 怀孕期间抑郁症复发非常普遍，特别是在患有复发性抑郁症的妇女中。 与妊娠期抑郁复发相关的孕产妇精神病发病率令人担忧， 怀孕期间和产后期间未经治疗的情绪障碍对儿童发育的影响。而 抗抑郁药维持治疗是复发性抑郁症女性的标准治疗， 存在关于胎儿暴露于这些试剂的已知和未知影响;可以理解的是，许多孕妇 妇女及其提供者在怀孕期间寻求药物治疗的非药物替代方案。 基于正念的认知疗法（MBCT）在预防抑郁症复发方面是有效的， 与常规护理相比，孕妇可以获得更好的护理，并且可以使用数字交付进行扩展。我们提出一个务实的 一项在正常孕妇（N = 500）中比较MBCT与常规护理（UC）的有效性试验， 用维持性抗抑郁药治疗复发性抑郁症。这项研究将在该大学进行 科罗拉多州博尔德（UCB; PI Dimidjian）和马萨诸塞州总医院（MGH; PI Cohen）使用 协作RO1机制。鉴于每个项目带来的独特专长， 建议的调查地点。具体来说，UCB网站提供实用的随机试验的专业知识 和MBCT为孕妇，和MGH网站提供专业知识，在前瞻性监测孕妇 有情绪障碍的女性我们将解决三个主要目标：1）检查抑郁症的相对风险 复发和减少随机分配到数字MBCT或UC的妇女之间的症状负担; 2）检查 随机接受正念认知疗法但停用抗抑郁药妇女抑郁复发风险 治疗组和随机分配至UC组、停止抗抑郁药治疗的受试者， 选择算法，询问MBCT与抗抑郁药维持治疗对谁有效; 以及3）检查数字MBCT与关键假定目标的结合程度。系统的调查 干预措施可以降低怀孕期间抑郁症复发的风险，特别是在"高危"人群中 最大限度地减少育龄妇女在关键时期复发抑郁症的发病率。