How Does Mindful Mood Balance for Moms Work?

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05000879
Study type	Interventional
Source	University of Colorado, Boulder
Contact
Status	Completed
Phase	N/A
Start date	November 16, 2018
Completion date	August 20, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.