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Mindful Moms Randomized Control Trial

Mindful Moms Randomized Control Trial Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04886856
Enrollment
200
Registered
2021-05-14
Start date
2021-10-15
Completion date
2026-06-30
Last updated
2026-08-20

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

Conditions

Depression

Keywords

pregnancy

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.

Detailed description

The Mindful Moms Study is a randomized controlled trial, in which participants will be randomly assigned (like the flip of a coin) to either the "Mindful Moms" group (12 weeks of group-based prenatal yoga) or the "Prenatal Education Circle" group (12 weeks of group-based prenatal education). 200 pregnant women will participate over the course of the study.

Interventions

BEHAVIORALMindful Moms

Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.

Twelve 75 minutes weekly group sessions involving prenatal education (for example, what to expect during your pregnancy, during labor and delivery, and after the delivery of your child).

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

Inclusion criteria

1. pregnant woman at 12-26 weeks gestation at baseline visit; 2. ≥age 18; 3. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS) or a score ≥2 on the PHQ-2; 4. able to read, write, and understand English or Spanish; 5. has not been told by a healthcare provider to avoid physical activity; 6. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy.

Exclusion criteria

Does not meet the inclusion criteria above.

Design outcomes

Primary

MeasureTime frameDescription
Change in Depressive symptom severityBaseline to postpartum, about 8 monthsDepressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The EDPS is a widely used and validated measure of depressive symptoms, with 10 questions appropriate for the prenatal and postpartum woman; a score ≥10 (range 0-30) suggests possible depressive symptoms.

Secondary

MeasureTime frameDescription
Change in anxietyBaseline to postpartum, about 8 monthsAnxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPatricia Kinser, PhD

Virginia Commonwealth University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026