Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

May 10, 2023 updated by: Lee S. Cohen, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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

Arm 2

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital delivery of MBCT (Mindful Mood Balance for Moms)
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy
12-week program that emphasizes mindfulness and cognitive behavioral skills
No Intervention: Usual Care
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Relapse of Depression
Time Frame: Randomization through 6 months postpartum
Depression relapse from randomization through 6 month postpartum
Randomization through 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Mental Health (NIMH)
University of Colorado, Boulder

Investigators

  • Principal Investigator: Sona Dimidjian, PhD, University of Colorado, Boulder
  • Principal Investigator: Lee S Cohen, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Actual)

March 21, 2022

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P001472
  • R01MH117253 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.

IPD Sharing Time Frame

Data will become available 6 months after study start-up and will continue to be available throughout the study.

IPD Sharing Access Criteria

Interested investigators will be asked to submit a proposal form, which will be reviewed by the principal investigator for scientific integrity and adherence to ethical guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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