Clinical trial NCT02387424: Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
Official title: Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Pregnancy
Depression
Keywords: depression
mindfulness
pregnancy
prevention
cognitive behavioral therapy
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Emory University
name: Kaiser Permanente
name: National Institute of Mental Health (NIMH)
First posted: 2015-03-13
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Engagement (class attendance)
timeFrame: Up to 8 weeks
measure: Client Satisfaction (CSQ-8)
timeFrame: Up to 8 weeks
measure: MBCT-PD Adherence Scale (MBCT-PD-AS)
timeFrame: Up to 8 weeks
measure: Change in Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: Up to 6 months postpartum
measure: Change in Edinburgh Postpartum Depression Scale (EPDS)
timeFrame: Up to 6 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Kaiser Permanente
state: Georgia
Study officials:
affiliation: University of Colorado, Boulder
name: Sona Dimidjian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Sherryl Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
References: