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

Phase

N/A

Condition

Pregnancy

Depression

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT02391870

13-0353-01

R34MH083866

Ages > 18
Female

Study 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.

Eligibility Criteria

Inclusion

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

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 notprovided by the study protocol
Women with any medical conditions that would preclude participation, includinghigh-risk pregnancy

Study Design

November 01, 2008

March 31, 2011

Study 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.

Connect with a study center

University of Colorado Boulder
Boulder, Colorado 80309
United States
Site Not Available
Kaiser Permanente Colorado
Denver, Colorado 80234
United States
Site Not Available
Emory University
Atlanta, Georgia 30322
United States
Site Not Available
Kaiser Permanente
Atlanta, Georgia 30328
United States
Site Not Available

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