Mindful Moms program for pregnant women with depression
Mindful Moms Randomized Control Trial Study
This study tests if a 12-week yoga program can help pregnant women with depression feel better compared to a group that just gets prenatal education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT04886856 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of the 'Mindful Moms' program, which involves 12 weeks of group-based prenatal yoga, compared to a control group receiving 12 weeks of prenatal education workshops. The trial will randomly assign 200 pregnant women experiencing depressive symptoms to either intervention group. The goal is to assess improvements in mood and health among participants. The study focuses on minority women and those with lower income or educational attainment.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, between 12-26 weeks gestation, who identify as a minority and exhibit depressive symptoms.
Not a fit: Patients who do not meet the inclusion criteria, such as those without depressive symptoms or who have a consistent yoga practice, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mood and overall health for pregnant women experiencing depression.
How similar studies have performed: Other studies have shown positive outcomes with yoga interventions for depression, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Kinser, PhD — Virginia Commonwealth University
- Study coordinator: Patricia Kinser, PhD
- Email: kinserpa@vcu.edu
- Phone: 804-828-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.