An interventional study of MBCT-PD in Pregnancy, Depression and Postpartum Depression, sponsored by University of Colorado, Boulder. Completed at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Prevention
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.
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:
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 49 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)
Behavioral: MBCT-PD
Using an iterative process, the investigators modified MBCT to include a focus on perinatal depression (MBCT-PD). The modifications took into account developmental processes associated with the perinatal period, characteristics and correlates of perinatal depression, and the physical aspects of pregnancy.
Engagement
Engagement is operationalized in-part as class attendance, with completion is defined as attendance at a minimum of four classes, and daily home practice recorded daily as the number of times of practice and type of practice, which are classified as either formal or informal practice.
Time frame: Up to 8 weeks
Client Satisfaction
Participant satisfaction will be evaluated by the CSQ-8, which is designed to yield a homogeneous estimate of general satisfaction with services. An exit interview also will be completed at 6-months postpartum.
Time frame: Up to 8 weeks
MBCT-PD Adherence Scale (MBCT-PD-AS)
Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.
Time frame: Up to 8 weeks
Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)
Rate of depressive relapse and time to relapse will be assessed using the LIFE, which provides a retrospective assessment of relapse or recurrence based on a semi-structured interview according to DSM-IV-TR diagnostic criteria.
Time frame: Up to 6 months postpartum
Change in Edinburgh Postpartum Depression Scale (EPDS)
Change in the severity of depressive symptoms will be evaluated by the Edinburgh Postpartum Depression Scale (EPDS), which is the most widely used self-report measure of antenatal and postpartum depression.
Time frame: Up to 6 months postpartum
The record gives a start of Nov 2008, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Colorado, Boulder