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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02391870
Other study ID # 13-0353-01
Secondary ID R34MH083866
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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