Mindful Moms / Prenatal Education / Depression · Interventional Study

Mindful Moms Randomized Control Trial

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed randomized controlled trial registered at ClinicalTrials.gov comparing a mindfulness-based behavioral intervention (Mindful Moms) to prenatal education for depression in pregnant women. No results have been posted in this registry record, making it impossible to assess efficacy or interpret clinical significance.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Depression; Female; age from 18 Years. Intervention: Mindful Moms. Compared with: Prenatal Education — Active Comparator. n = 200. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed trial registry record with no posted results; the study design and planned enrollment are documented but outcomes remain unreported in this source.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in Depressive symptom severity (assessed at Baseline to postpartum, about 8 months)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationDepression; Female; age from 18 Years

Sample size200

InterventionMindful Moms

ComparatorPrenatal Education — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment200

Actual enrollment200

Primary outcome measureChange in Depressive symptom severity, Baseline to postpartum, about 8 months

Caveats

Results are not reported in this registry record; no efficacy data, effect sizes, or statistical tests are available
Blinding status, randomization method, and allocation concealment are not described
No power calculation or target effect size is stated
No information on baseline characteristics, dropout rates, or adherence is provided

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized control trial comparing behavioral intervention to active comparator

Directness

strong

Primary outcome directly measures depressive symptom severity in pregnant women

Consistency

insufficient

No results reported; consistency cannot be assessed

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or attrition

Sample adequacy

moderate

Planned enrollment 200 participants; actual enrollment completed but power calculation not stated

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04886856). This is a study registration, not published results. Lead sponsor: Virginia Commonwealth University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ACTUAL). Conditions: Depression. Interventions: BEHAVIORAL: Mindful Moms; BEHAVIORAL: Prenatal Education. Primary outcome measures: Change in Depressive symptom severity , Baseline to postpartum, about 8 months. Brief summary: The purpose of this study is to test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT04886856Virginia Commonwealth UniversityMindful MomsPrenatal EducationDepression