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

NCT02391870 | Completed DMC

• 2 other identifiers: 13-0353-01R34MH083866
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

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.

Conditions

Pregnancy; Depression; Postpartum Depression

Keywords

depression; mindfulness; pregnancy; prevention; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (5)

• Engagement

  Engagement is operationalized in-part as class attendance, with completion is defined as attendance at a minimum of four classes, and daily home practice recorded daily as the number of times of practice and type of practice, which are classified as either formal or informal practice.

  Up to 8 weeks

• Client Satisfaction

  Participant satisfaction will be evaluated by the CSQ-8, which is designed to yield a homogeneous estimate of general satisfaction with services. An exit interview also will be completed at 6-months postpartum.

  Up to 8 weeks

• MBCT-PD Adherence Scale (MBCT-PD-AS)

  Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.

  Up to 8 weeks

• Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)

  Rate of depressive relapse and time to relapse will be assessed using the LIFE, which provides a retrospective assessment of relapse or recurrence based on a semi-structured interview according to DSM-IV-TR diagnostic criteria.

  Up to 6 months postpartum

• Change in Edinburgh Postpartum Depression Scale (EPDS)

  Change in the severity of depressive symptoms will be evaluated by the Edinburgh Postpartum Depression Scale (EPDS), which is the most widely used self-report measure of antenatal and postpartum depression.

  Up to 6 months postpartum

Study Arms (1)

MBCT-PD

EXPERIMENTAL

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

Behavioral: MBCT-PD

Interventions

MBCT-PD 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.

MBCT-PD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• Emory University: collaborator
• Kaiser Permanente: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Kaiser Permanente Colorado

Denver, Colorado, 80234, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Kaiser Permanente

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Depression; Depression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sona Dimidjian, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Sherryl Goodman, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: November 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

US (4)