Mindful Moms Randomized Control Trial Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Depressive symptom severity
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •pregnant woman at 12-26 weeks gestation at baseline visit;
- •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;
- •current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
- •able to read, write, and understand English;
- •has not been told by a healthcare provider to avoid physical activity;
- •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.
Outcomes
Primary Outcomes
Change in Depressive symptom severity
Time Frame: Baseline to postpartum, about 8 months
Depressive 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 Outcomes
- Change in anxiety(Baseline to postpartum, about 8 months)
- Change in stress(Baseline to postpartum, about 8 months)