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

NCT ID: NCT02387424

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-05-31

Brief Summary

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).

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.

Conditions

Postpartum Depression; Pregnancy; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• 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

The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.

OAR

Ongoing Assessment and Referral (OAR)

Group Type: ACTIVE_COMPARATOR

OAR

Intervention Type: BEHAVIORAL

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.

Interventions

MBCT-PD

The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.

Intervention Type: 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.

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

13-0353-02

Identifier Type: -

Identifier Source: org_study_id