NCT03623620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

August 2, 2018

Results QC Date

March 30, 2023

Last Update Submit

May 10, 2023

Conditions

DepressionPregnancy RelatedAntenatal Depression

Keywords

DepressionPregnancyAntidepressantsMindfulnessMedication use during pregnancyDepression RelapseSuicidal ideation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Experiencing Relapse of Depression

    Depression relapse from randomization through 6 month postpartum

    Randomization through 6 months postpartum

Study Arms (2)

Digital delivery of MBCT (Mindful Mood Balance for Moms)

EXPERIMENTAL

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.

Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy

Usual Care

NO INTERVENTION

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

Interventions

Digital Delivery of Mindfulness-Based Cognitive TherapyBEHAVIORAL

12-week program that emphasizes mindfulness and cognitive behavioral skills

Digital delivery of MBCT (Mindful Mood Balance for Moms)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • Age 18 or older
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 16449615BACKGROUND

  • 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.

    PMID: 26654212BACKGROUND

MeSH Terms

Conditions

DepressionSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Results Point of Contact

Title
Lee Cohen, MD
Organization
Massachusetts General Hospital, Center for Women's Mental Health
lcohen2@mgh.harvard.edu
617-724-8020

Study Officials

  • Lee S Cohen, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Sona Dimidjian, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Women's Mental Health

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 9, 2018

Study Start

March 12, 2019

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

June 6, 2023

Results First Posted

June 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will become available 6 months after study start-up and will continue to be available throughout the study.
Access Criteria
Interested investigators will be asked to submit a proposal form, which will be reviewed by the principal investigator for scientific integrity and adherence to ethical guidelines.

Locations

US(2)