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Completed

NCT Number: NCT02387424

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

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).

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Key information

Conditions

Postpartum Depression Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder, Boulder, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCT-PD

Behavioral

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

OAR

Behavioral

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.

Primary outcomes

  1. Engagement (class attendance)

    Time frame: 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.

  2. Client Satisfaction (CSQ-8)

    Time frame: 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.

  3. MBCT-PD Adherence Scale (MBCT-PD-AS)

    Time frame: Up to 8 weeks

    Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.

  4. Change in Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)

    Time frame: 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.

  5. Change in Edinburgh Postpartum Depression Scale (EPDS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • Emory University
  • Kaiser Permanente
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2015
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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