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

University of Colorado Boulder (CU)

Status

Completed

Conditions

Depression

Postpartum Depression

Pregnancy

Treatments

Behavioral: MBCT-PD

Behavioral: OAR

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02387424

13-0353-02

R34MH083866 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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