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

2/2-预防复发性抑郁症孕妇的抑郁症复发

• 批准号: 9920209
• 负责人: LEE S COHEN
• 金额: $ 49.7万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 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/9920209
• 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，特别是在患有抑郁症的妇女中。 复发性抑郁症孕期抑郁复发与母亲精神病发病率的关系 怀孕是一个令人关注的问题，怀孕期间未经治疗的情绪障碍的影响也是如此， 产后期对儿童发育的影响。虽然抗抑郁药的维持治疗是 复发性抑郁症妇女的护理标准， 胎儿暴露于这些药物的未知影响;可以理解，许多孕妇和 他们的提供者寻求非药物替代药物治疗， 怀孕基于正念的认知疗法（MBCT）是有效的预防 与常规护理相比，孕妇抑郁症复发， 数字交付。我们提出了一个务实的有效性试验比较MBCT常规护理（UC） 在接受维持治疗的复发性抑郁症的正常妊娠女性（N=500）中 抗抑郁药本研究将在科罗拉多大学博尔德分校（UCB; PI）进行 Dimidjian）和马萨诸塞州总医院（MGH; PI Cohen）使用协作RO 1 机制鉴于每个研究中心都有独特的专门知识， 拟议的调查。具体而言，UCB网站提供实用的专业知识， 随机试验和孕妇的MBCT，MGH网站提供以下方面的专业知识 对有情绪障碍的孕妇进行前瞻性监测。我们将讨论三个主要问题 目的：1）研究抑郁症复发和症状负担减轻的相对风险 随机分配到数字MBCT或UC的女性之间; 2）检查抑郁风险 随机分配至MBCT组的女性在停用抗抑郁药后的复发率 治疗组和随机分配至UC且停止抗抑郁药治疗的患者， 治疗选择算法，询问MBCT与 抗抑郁药维持; 3）检查数字MBCT在多大程度上参与了关键的 假定目标系统调查干预措施，可以减少抑郁症的风险 怀孕期间复发，特别是在“高危”人群中， 育龄妇女在生命的关键时期反复抑郁。