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Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

NCT03623620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-06-06

Study results available
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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.

Conditions

  • Depression
  • Pregnancy Related
  • Antenatal Depression

Interventions

BEHAVIORAL

Digital Delivery of Mindfulness-Based Cognitive Therapy

12-week program that emphasizes mindfulness and cognitive behavioral skills

Sponsors & Collaborators

  • University of Colorado, Boulder

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lee S Cohen, MD · Massachusetts General Hospital

  • Sona Dimidjian, PhD · University of Colorado, Boulder

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623620 on ClinicalTrials.gov