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NCT03623620

Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

Completed NA Results posted Last updated 6 June 2023
What this trial tests

NA trial testing Digital Delivery of Mindfulness-Based Cognitive Therapy in Depression in 500 participants. Completed in 21 March 2022.

Timeline
12 March 2019
Primary endpoint
21 March 2022
21 March 2022

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment500
Start date12 March 2019
Primary completion21 March 2022
Estimated completion21 March 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

18 and older, female only, with Depression or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Relapse of Depression Primary · Randomization through 6 months postpartum

Depression relapse from randomization through 6 month postpartum

GroupValue95% CI
Digital Delivery of MBCT (Mindful Mood Balance for Moms)81
Usual Care111

Adverse events — posted to ClinicalTrials.gov

Time frame: March 12, 2019 to September 12, 2021 (18 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Digital Delivery of MBCT (Mindful Mood Balance for Moms)
Serious: 0/249 (0%)
Deaths: 0/249
Usual Care
Serious: 0/251 (0%)
Deaths: 0/251
Other adverse events (1 terms — click to expand)

ReactionSystemDigital Delivery of MBCT (…Usual Care
All events categorized as "unexpected" and "non-Severe"Pregnancy, puerperium and perinatal conditions

Data from ClinicalTrials.gov NCT03623620 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Testing a Behavioral Activation Gaming App for Depression During Pregnancy: Multimethod Pilot Study.
    Vanderkruik RC, Ferguson C, Kobylski LA, Locascio JJ, et al · · 2024 · cited 5× · PMID 38277191 · DOI 10.2196/44029

Verify or expand the search:

Other recruiting trials for Depression

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03623620.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing