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

Phase One: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Postpartum Depression; Pregnancy
• Intervention / Treatment: Behavioral: MBCT-PD

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder
    • Denver, Colorado, United States, 80234
      • Kaiser Permanente Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30328
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBCT-PD; Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: National Institute of Mental Health (NIMH); Emory University; Kaiser Permanente
• Investigators: Principal Investigator: Sona Dimidjian, PhD, University of Colorado, Boulder; Principal Investigator: Sherryl Goodman, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: depression; cognitive behavioral therapy; pregnancy; prevention; mindfulness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 13-0353-01; R34MH083866 (U.S. NIH Grant/Contract)