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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391870
• Other study ID #: 13-0353-01
• Secondary ID: R34MH083866
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2020
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Kaiser Permanente	Atlanta	Georgia
United States	University of Colorado Boulder	Boulder	Colorado
United States	Kaiser Permanente Colorado	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Emory University, Kaiser Permanente, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 8 weeks
Primary	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.	Up to 8 weeks
Primary	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.	Up to 8 weeks
Primary	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.	Up to 6 months postpartum
Primary	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.	Up to 6 months postpartum