How Does Mindful Mood Balance for Moms Work?

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Pregnancy Related, Antenatal Depression, Depression, Postpartum

Intervention / Treatment
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* Behavioral: MMB for Moms


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMB for Moms<br>Subjects will receive digital delivery of Mindful Mood Balance for Moms for 12 weeks. Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. | Behavioral: MMB for Moms<br>* 12-week program that emphasizes mindfulness and cognitive behavioral skills<br>|
| No Intervention: Waitlist Control<br>Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in depression symptoms | Change in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9) | Through 6-month follow-up | 
| Rate of change in decentering | Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale | Through 6-month follow-up | 
| Rate of change in self-compassion | Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS) | Through 6-month follow-up | 
| Depressive Relapse Status | 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. | Through 6-month follow-up | 
| Rate of change in anxiety symptoms | Change in the severity of anxiety symptoms will be evaluated by the 3. Generalized Anxiety Disorder-7 (GAD-7) | Through 6-month follow-up |