N/A N=500 Randomized Single-blind Prevention

Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

Depression · Pregnancy Related · Antenatal Depression

Bottom Line

View on ClinicalTrials.gov: NCT03623620 ↗

Enrolled (actual)

500

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Number of Participants Experiencing Relapse of Depression — 81; 111 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Digital Delivery of Mindfulness-Based Cognitive Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Massachusetts General Hospital
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Relapse of Depression	81; 111	—

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.

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03623620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.