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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要怀孕期间的抑郁缓解非常普遍，尤其是复发性抑郁症。与反思性缓解相关的孕产妇精神病发病率怀孕期间未经治疗的情绪障碍的影响以及产后儿童发育时期。而维持抗抑郁治疗是针对复发性抑郁症的妇女的护理标准，对已知和胎儿暴露于这些药物的未知影响；可以理解的是，许多孕妇和他们的提供者在期间寻求非药理学替代药物治疗怀孕。基于正念的认知疗法（MBCT）在预防方面有效与通常的护理相比，孕妇的抑郁缓解数字交付。我们提出了一项务实的有效性试验，将MBCT与常规护理（UC）进行了比较在正式孕妇（n = 500）中，经常性抑郁症用维持治疗抗抑郁药。该研究将在科罗拉多大学（UCB; pi）进行。 Dimidjian）和马萨诸塞州综合医院（MGH； PI Cohen）使用协作RO1 机制。鉴于每个网站带来的独特专业知识是合理的拟议的调查。具体而言，UCB网站提供了务实的专业知识孕妇的随机试验和MBCT，MGH网站提供了专业知识对情绪障碍的孕妇的前瞻性监测。我们将解决三个主要目的：1）检查抑郁缓解和减轻症状的相对风险在随机分配数字MBCT或UC的妇女之间； 2）检查抑郁症的风险在停止抗抑郁药的MBCT的女性之间中继治疗和那些将抗抑郁药治疗的UC随机分配给UC，并应用一种治疗选择算法，以询问与MBCT相对于MBCT与谁有效的方法抗抑郁药维持； 3）检查数字MBCT参与密钥的程度推定目标。可能会减轻抑郁症风险的干预措施的系统投资怀孕期间的复发，特别是在“处于风险”的种群中，在生殖老年妇女生活中关键时期的复发抑郁症。