Mindful Moms Randomized Control Trial

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Mindful Moms; Behavioral: Prenatal Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04886856

HM20021720

1R01NR020220 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. pregnant woman at 12-26 weeks gestation at baseline visit;
2. defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, & Children [WIC] benefits in Virginia and/or educational attainment ≤high school education;
3. ≥age 18;
4. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
5. able to read, write, and understand English;
6. has not been told by a healthcare provider to avoid physical activity;
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Mindful Moms

Experimental group

Description:

Weekly "Mindful Moms" sessions

Treatment:

Behavioral: Mindful Moms

Prenatal Education

Active Comparator group

Description:

Weekly prenatal education sessions

Treatment:

Behavioral: Prenatal Education