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How Does Mindful Mood Balance for Moms Work?

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05000879
Enrollment
60
Registered
2021-08-11
Start date
2018-11-16
Completion date
2019-08-20
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal Depression, Depression, Depression, Postpartum, Pregnancy Related

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.

Interventions

BEHAVIORALMMB for Moms

12-week program that emphasizes mindfulness and cognitive behavioral skills

Sponsors

University of Colorado, Boulder
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. female, 2. pregnant or having had a child within the past 36 months, \* 3. 18 years of age or older, 4. 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?) 5. a current PHQ-9 score of \<= 14, and 6. endorses ability to read and write fluently in English.

Exclusion criteria

1. meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 \>= 15), 2. current imminent suicidality (as assessed by the PHQ-9), and 3. indication of other disorders or symptoms that necessitate priority treatment.

Design outcomes

Primary

MeasureTime frameDescription
Rate of change in depression symptomsThrough 6-month follow-upChange in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9)
Rate of change in decenteringThrough 6-month follow-upChange in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale
Rate of change in self-compassionThrough 6-month follow-upChange in self-compassion will be evaluated by the Self-Compassion Scale (SCS)
Depressive Relapse StatusThrough 6-month follow-upRate 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.
Rate of change in anxiety symptomsThrough 6-month follow-upChange in the severity of anxiety symptoms will be evaluated by the 3. Generalized Anxiety Disorder-7 (GAD-7)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026