The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

NCT ID: NCT02391870

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-03-31

Brief Summary

Pregnant women with histories of depression are at high risk of depressive relapse during the perinatal period, and options for relapse prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women.

This study is the first phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD). It is being conducted in a collaboration between the University of Colorado, Emory University, and Kaiser Permanente at Colorado and Georgia.

Detailed Description

Mindfulness-based cognitive therapy (MBCT) represents one of the most important recent developments in the effort to prevent recurrent depression. Explicitly designed to modify core underlying vulnerability factors among recovered individuals with histories of depression, MBCT may have high applicability to the prevention of perinatal depression (PD).

During this phase of the project the investigators will employ an iterative process to develop, within routine obstetric clinical settings, the MBCT-PD program across a two-center open trial of pregnant women at high risk of perinatal depression. During this phase, the investigators will modify the standard MBCT approach to be sensitive and specific to women at high risk of perinatal depressive relapse or recurrence based on previous history of depression and will address the following aims:

• Specific Aim 1: To examine the feasibility of MBCT-PD with respect to identification and enrollment of women at-risk of perinatal depression based on a history of depression.
• Specific Aim 2: To examine the engagement of women with the MBCT-PD approach with respect to retention, completion of daily practice assignments, and satisfaction
• Specific Aim 3: To examine the clinical outcomes including change in depression symptom levels and rates of relapse/recurrence over the course of the intervention and through a 6-month postpartum follow-up.

Conditions

Pregnancy; Depression; Postpartum Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MBCT-PD

Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)

Group Type: EXPERIMENTAL

MBCT-PD

Intervention Type: BEHAVIORAL

Using an iterative process, the investigators modified MBCT to include a focus on perinatal depression (MBCT-PD). The modifications took into account developmental processes associated with the perinatal period, characteristics and correlates of perinatal depression, and the physical aspects of pregnancy.

Interventions

MBCT-PD

Using an iterative process, the investigators modified MBCT to include a focus on perinatal depression (MBCT-PD). The modifications took into account developmental processes associated with the perinatal period, characteristics and correlates of perinatal depression, and the physical aspects of pregnancy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant up to 32 weeks gestation
• Meeting criteria for prior depression
• Failure to meet criteria for a diagnosis of MDD in the last two months
• Available for group intervention scheduled meetings

Exclusion Criteria

• Presence of schizophrenia or schizoaffective disorder
• Presence of bipolar disorder or current psychosis
• Presence of organic mental disorder or pervasive developmental delay
• Presence of current eating disorder
• Presence of current substance abuse or dependence
• Presence of antisocial, borderline, or schizotypal personality disorder
• Presence of imminent suicide or homicide risk
• Presence of any other axis I or II disorders that necessitate priority treatment not provided by the study protocol
• Women with any medical conditions that would preclude participation, including high-risk pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

Sona Dimidjian

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sona Dimidjian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Sherryl Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

University of Colorado Boulder

Boulder, Colorado, United States

Kaiser Permanente Colorado

Denver, Colorado, United States

Emory University

Atlanta, Georgia, United States

Kaiser Permanente

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

R34MH083866

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-0353-01

Identifier Type: -

Identifier Source: org_study_id