The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

Depression Clinical Trial

Official title: Phase One: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression
• Pregnancy

• NCT number: NCT02391870
• Study type: Interventional
• Source: University of Colorado, Boulder
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Completion date: March 2011