Clinical trial NCT02391870: The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression
Official title: Phase One: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Depression
Postpartum 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: 2015-03-18
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

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
timeFrame: Up to 8 weeks
measure: Client Satisfaction
timeFrame: Up to 8 weeks
measure: MBCT-PD Adherence Scale (MBCT-PD-AS)
timeFrame: Up to 8 weeks
measure: 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: