A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers

University of Colorado, Boulder1 site in 1 country60 target enrollmentNovember 16, 2018

ConditionsDepression Pregnancy Related Antenatal Depression Depression, Postpartum

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: University of Colorado, Boulder
Enrollment: 60
Locations: 1
Primary Endpoint: Rate of change in anxiety symptoms
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this investigation is to conduct a randomized trial comparing a web-based Mindful Mood Balance for Moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories.

Detailed Description

Mindfulness-based cognitive therapy (MBCT) prevents depressive relapse and reduces residual depression symptoms among adults with recurrent depression not currently in episode. Women in perinatal or early parenting years constitute a significant portion of this at-risk population with a history of depression for whom MBCT was designed. Novel delivery formats that provide access to core knowledge and skills of MBCT could increase public health impact-particularly for perinatal or early parenting women-but it is unclear whether such formats have comparable mental health outcomes and changes in putative targets as in-person MBCT. In the present study, we planned to randomize 60 pregnant or early parenting women with a history of major depression and current residual depressive symptoms to MMB for Moms, a web-based course that teaches skills from MBCT customized specifically for pregnant and postpartum women, or waitlist control. We planned to address the following specific aims: Aim 1. We evaluated the extent to MMB for Moms was associated with significant reduction in residual depression symptoms as compared to WLC. We predicted the rate of change in depression symptoms across the study would be greater on average for participants randomized to MMB for Moms relative to those randomized to WLC. Aim 2. We evaluated the extent to MMB for Moms significantly engaged the putative target of decentering as compared to WLC. We predicted the rate of change in decentering across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC. Aim 3. We evaluated the extent to MMB for Moms significantly engaged the putative target of self-compassion as compared to WLC. We predicted the rate of change in self-compassion across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.

Registry

clinicaltrials.gov

Start Date

November 16, 2018

End Date

August 20, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Colorado, Boulder

Responsible Party

Principal Investigator

CHRISTINA METCALF

Senior Instructor

University of Colorado, Boulder

Eligibility Criteria

Inclusion Criteria

•pregnant or having had a child within the past 36 months, \*
•18 years of age or older,
•having a history of one or more prior major depressive episode (as assessed by a single question, "Have you had a history of mood concerns or major depression?")
•a current PHQ-9 score of \<= 14, and
•endorses ability to read and write fluently in English.

Exclusion Criteria

•meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 \>= 15),
•current imminent suicidality (as assessed by the PHQ-9), and
•indication of other disorders or symptoms that necessitate priority treatment.