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

Sponsor

University of Colorado, Boulder (Other)

Overall Status

Completed

CT.gov ID

NCT02391870

Collaborator

Emory University (Other), Kaiser Permanente (Other), National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

Arm

27.9

Duration (Months)

12.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Depression Postpartum Depression	Behavioral: MBCT-PD	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBCT-PD 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.

Arm

Intervention/Treatment

Experimental: MBCT-PD

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.

Outcome Measures

Primary Outcome Measures

Engagement [Up to 8 weeks]
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.
Client Satisfaction [Up to 8 weeks]
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.
MBCT-PD Adherence Scale (MBCT-PD-AS) [Up to 8 weeks]
Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.
Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE) [Up to 6 months postpartum]
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.
Change in Edinburgh Postpartum Depression Scale (EPDS) [Up to 6 months postpartum]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Boulder	Boulder	Colorado	United States	80309
2	Kaiser Permanente Colorado	Denver	Colorado	United States	80234
3	Emory University	Atlanta	Georgia	United States	30322
4	Kaiser Permanente	Atlanta	Georgia	United States	30328