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Completed

NCT Number: NCT05000879

How Does Mindful Mood Balance for Moms Work?

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female,
  • 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.

Treatment and study plan

MMB for Moms

Behavioral

12-week program that emphasizes mindfulness and cognitive behavioral skills

Primary outcomes

  1. Rate of change in depression symptoms

    Time frame: Through 6-month follow-up

    Change in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9)

  2. Rate of change in decentering

    Time frame: Through 6-month follow-up

    Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale

  3. Rate of change in self-compassion

    Time frame: Through 6-month follow-up

    Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS)

  4. Depressive Relapse Status

    Time frame: Through 6-month follow-up

    Rate of depressive relapse will be assessed using the Lifetime Depression Assessment Self-report (LIDAS), adapted to reference the past 3 or 6 months based on survey completion.

  5. Rate of change in anxiety symptoms

    Time frame: Through 6-month follow-up

    Change in the severity of anxiety symptoms will be evaluated by the 3. Generalized Anxiety Disorder-7 (GAD-7)

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2021
Registry last updated
May 23, 2024

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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