Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence

Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence

Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence 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 second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).

Study Overview

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

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 conduct a two-site pilot randomized clinical trial with pregnant women at high-risk of perinatal depression, comparing the efficacy of MBCT-PD to a control group in the prevention of depressive relapse and recurrence. Participants assigned to the control group will receive "ongoing assessment and referral" (OAR), consisting of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. The investigators will randomly assign participants at each site to 8 weeks of MBCT-PD or OAR.

During this phase, the investigators will address the following aims:

• Specific Aim 1: To test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving OAR, including lower rates of depressive relapse/recurrence and lower depressive symptom severity as compared to participants receiving OAR.
• Specific Aim 2: To explore the secondary hypotheses that participants receiving MBCT-PD will report improved functioning as compared to participants receiving OAR on a range of secondary outcomes, including indices of anxiety and stress and obstetrical complications.
• Specific Aim 3: To explore potential moderators and mediators of depression outcomes.
• Specific Aim 4: To train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity.

• Study Type: Interventional
• Enrollment (Actual): 86
• 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: 18 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBCT-PD; Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)	Behavioral: MBCT-PD; The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.
Active Comparator: OAR; Ongoing Assessment and Referral (OAR)	Behavioral: OAR; Ongoing Assessment and Referral (OAR) consists of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Engagement (class attendance)	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 (CSQ-8)	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
Change in 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

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: July 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 13, 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; Pathologic Processes; Mood Disorders; Disease Attributes; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Recurrence; Depression, Postpartum
• Other Study ID Numbers: 13-0353-02; R34MH083866 (U.S. NIH Grant/Contract)