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Clinical Trials/NCT03623620
NCT03623620
Completed
Not Applicable

Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

Massachusetts General Hospital2 sites in 1 country500 target enrollmentMarch 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Massachusetts General Hospital
Enrollment
500
Locations
2
Primary Endpoint
Number of Participants Experiencing Relapse of Depression
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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. MMB for Moms delivers digitally both the content and structure of in-person MBCT, and may be a promising intervention for pregnant women with suicidal ideation. Investigators will also explore the safety, feasibility, and acceptability of enrolling pregnant women with any reports of suicidal ideation or behavior in a proof of concept randomized controlled trial comparing MMB for Moms to enhanced usual care.

Registry
clinicaltrials.gov
Start Date
March 12, 2019
End Date
March 21, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lee S. Cohen, MD

Director, Center for Women's Mental Health

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of Participants Experiencing Relapse of Depression

Time Frame: Randomization through 6 months postpartum

Depression relapse from randomization through 6 month postpartum

Study Sites (2)

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