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

Sponsor

University of Colorado, Boulder (Other)

Overall Status

Completed

CT.gov ID

NCT02387424

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

21.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression Pregnancy Depression	Behavioral: MBCT-PD Behavioral: OAR	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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBCT-PD Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)	Behavioral: MBCT-PD The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.
Active Comparator: OAR Ongoing Assessment and Referral (OAR)	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: MBCT-PD

Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD)

Behavioral: MBCT-PD

The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.

Active Comparator: OAR

Ongoing Assessment and Referral (OAR)

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Engagement (class attendance) [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 (CSQ-8) [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.
Change in 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