Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

NCT ID: NCT03623620

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2022-03-21

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.

Conditions

Depression; Pregnancy Related; Antenatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Delivery of Mindfulness-Based Cognitive Therapy

Intervention Type: BEHAVIORAL

12-week program that emphasizes mindfulness and cognitive behavioral skills

Usual Care

Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital Delivery of Mindfulness-Based Cognitive Therapy

12-week program that emphasizes mindfulness and cognitive behavioral skills

Intervention Type: BEHAVIORAL

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

• 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

• Age 18 or older
• Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a

• Pregnant women
• Age 18 or older
• Self-reported history of major depressive disorder
• Suicidal ideation as noted by item #9 of the PHQ-9

• 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
• Active mania, psychosis, or substance abuse (within the last 6 months)
• Immediate risk of self-harm
• Non-English speaking

Arm 1 Aim 1a

• 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

• Non-English speaking

Arm 1 Aim 1c

• Non-English speaking

Arm 2

• Diagnosis of bipolar or psychotic disorder
• Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lee S. Cohen, MD

Director, Center for Women's Mental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee S Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Sona Dimidjian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

University of Colorado Boulder

Boulder, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.

Reference Type: BACKGROUND

PMID: 16449615 (View on PubMed)

Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.

Reference Type: BACKGROUND

PMID: 26654212 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH117253

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018P001472

Identifier Type: -

Identifier Source: org_study_id