Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence

Depression Clinical Trial

Official title:

Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387424
• Other study ID #: 13-0353-02
• Secondary ID: R34MH083866
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: May 2013

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/recurrence during the perinatal period, and options for relapse/recurrence 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 second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).

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 conduct a two-site pilot randomized clinical trial with pregnant women at high-risk of perinatal depression, comparing the efficacy of MBCT-PD to a control group in the prevention of depressive relapse and recurrence. Participants assigned to the control group will receive "ongoing assessment and referral" (OAR), consisting of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. The investigators will randomly assign participants at each site to 8 weeks of MBCT-PD or OAR.

During this phase, the investigators will address the following aims:

• Specific Aim 1: To test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving OAR, including lower rates of depressive relapse/recurrence and lower depressive symptom severity as compared to participants receiving OAR.

• Specific Aim 2: To explore the secondary hypotheses that participants receiving MBCT-PD will report improved functioning as compared to participants receiving OAR on a range of secondary outcomes, including indices of anxiety and stress and obstetrical complications.

• Specific Aim 3: To explore potential moderators and mediators of depression outcomes.

• Specific Aim 4: To train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• 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
• Recurrence

Intervention

Behavioral:
• MBCT-PD
The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.
• OAR
Ongoing Assessment and Referral (OAR) consists of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia.

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 (class attendance)	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 (CSQ-8)	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	Change in 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