跳至主要内容
临床试验/NCT03623620
NCT03623620已完成不适用

Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

Massachusetts General Hospital4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
4
主要终点
Number of Participants Experiencing Relapse of Depression

研究概览

简要总结

The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only among euthymic pregnant women with recurrent depression treated with antidepressants.

In the supplemental arms we will investigate the prevalence, severity, longitudinal course, correlates, and predictors of suicidal ideation and behavior among women during pregnancy and the postpartum period.

详细描述

This study will address a significant gap in the evidence regarding effective approaches to prevent depressive relapse among women with recurrent depression who maintain euthymia using antidepressants and who wish to conceive or who are pregnant. Relapse rates of depression following antidepressant discontinuation among such women has been established, and the efficacy of MBCT in mitigating relapse risk in pregnant women with recurrent depression compared to UC also has been demonstrated. But the effectiveness of MBCT has not been tested in a definitive trial; the question of whether MBCT can mitigate risk for depressive relapse among pregnant women on antidepressants, including among those who discontinue antidepressants proximate to or during pregnancy, also has not been addressed.

Reproductive age women with recurrent depression and their healthcare providers need to know, first, if a scalable digital non-pharmacologic prevention approach is superior to UC in community settings, and second, whether MBCT can attenuate risk for depressive relapse among those who elect to discontinue maintenance antidepressant treatment proximate to or during pregnancy. Lastly, the capacity to identify which women are most likely to benefit from a non-pharmacologic or pharmacologic approach personalizes the risk benefit decision making process for reproductive age women on antidepressants planning to conceive or who are pregnant.

Investigators will test the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC, explore the specific benefit of MBCT relative to antidepressant discontinuation, and determine whether a treatment selection algorithm can predict whether MBCT or UC will work best for a specific participant.

The supplemental arms of this study will further investigate suicidal ideation and behavior in a perinatal population to better understand the prevalence, severity, longitudinal course, correlates and predictors of suicidal ideation and behavior among women during pregnancy and in the postpartum period.

Investigators will use a mixed methods approach of both cross-sectional and longitudinal study designs to characterize a real-world population of pregnant and postpartum women who have endorsed suicidality. Investigators will also use qualitative interviews, self-report instruments, and medical records to explore the extent to which community healthcare professionals providing care to perinatal women report the knowledge base and requisite skills to address suicidal ideation and behavior in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Ages 18 or older
  • History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated)
  • Euthymic or with residual symptoms (PHQ-9 ≤ 9)
  • No depressive relapse since last menstrual period
  • Currently or recently received antidepressants (within the three months prior to last menstrual period)
  • Presence of ongoing community provider

排除标准

  • Diagnosis of bipolar or psychotic disorder
  • Active mania, psychosis, or substance abuse (within the last 6 months)
  • Immediate risk of self-harm
  • Non-English speaking
  • Inclusion and exclusion criteria for the participants in the supplemental arms of the study differ from the main study and are as follows:
  • Arm 1 Aim 1a
  • Inclusion Criteria:
  • Pregnant women (prior to 16 weeks gestation)
  • Age 18 or older
  • Presence of an ongoing community prescriber / provider
  • Suicidal ideation as noted by item #9 of the PHQ-9
  • History of recurrent depression, dysthymia or subsyndromal depression
  • Exclusion Criteria:
  • Diagnosis of bipolar or psychotic disorder
  • Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
  • Non-English speaking
  • Arm 1 Aim 1b
  • Inclusion Criteria:
  • Age 18 or older
  • Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a
  • Exclusion Criteria:
  • Non-English speaking
  • Arm 1 Aim 1c
  • Inclusion Criteria:
  • Pregnant women
  • Age 18 or older
  • Self-reported history of major depressive disorder
  • Suicidal ideation as noted by item #9 of the PHQ-9
  • Exclusion Criteria:
  • Non-English speaking
  • Inclusion Criteria:
  • Pregnant women (prior to 16 weeks gestation)
  • Age 18 or older
  • History of recurrent major depression prior to pregnancy (at least two prior episodes, one of which may be currently treated)
  • Euthymic or with residual symptoms (PHQ-9 </=9)
  • Presence of an ongoing community prescriber / provider
  • Current suicidal ideation as noted by item #9 of the PHQ-9 or past suicidal ideation as noted by item A3g on the MINI mood module
  • Exclusion Criteria:
  • Diagnosis of bipolar or psychotic disorder
  • Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
  • Non-English speaking

结局指标

主要结局

Number of Participants Experiencing Relapse of Depression

时间窗: Randomization through 6 months postpartum

Depression relapse from randomization through 6 month postpartum

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee S. Cohen, MD

Director, Center for Women's Mental Health

Massachusetts General Hospital

研究点 (4)

Loading locations...

相似试验