Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

Not Applicable

Completed

Conditions: Pregnancy Related
Depression
Antenatal Depression

Interventions: Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy

Registration Number: NCT03623620

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 500

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital delivery of MBCT (Mindful Mood Balance for Moms)	Digital Delivery of Mindfulness-Based Cognitive Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Relapse of Depression	Randomization through 6 months postpartum	Depression relapse from randomization through 6 month postpartum

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Colorado Boulder
🇺🇸
Boulder, Colorado, United States