Depression Clinical Trial
Official title:
Phase One: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression
Verified date | April 2020 |
Source | University of Colorado, Boulder |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder | Emory University, Kaiser Permanente, National Institute of Mental Health (NIMH) |
United States,
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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