Mindful Moms Randomized Control Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindful Moms, Prenatal Education.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mindful Moms Randomized Control Trial Study
Overview
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
- Behavioral Mindful Moms
Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers. - Behavioral Prenatal Education
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).
Primary outcome measures
- Change in Depressive symptom severity [Time frame: Baseline to postpartum, about 8 months]
Secondary outcome measures (2)
- Change in anxiety [Time frame: Baseline to postpartum, about 8 months]
- Change in stress [Time frame: Baseline to postpartum, about 8 months]
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;
- ≥age 18;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Virginia Commonwealth University — Richmond
Publications
- Kinser PA, Bodnar-Deren S, Amstadter AB, Lapato DM, Thacker LR, Johnson JA, Aubry C, Johnson A, Gault C, Hill-Thomas A, Russell S, Lanni S, Freeman A. Study protocol for the Mindful Moms Study: A randomized controlled trial evaluating a mindful movement intervention for marginalized pregnant people experiencing depression. Contemp Clin Trials. 2023 Sep;132:107302. doi: 10.1016/j.cct.2023.107302. E PMID 37500008
Identifiers
NCT: NCT04886856 · HM20021720 · 1R01NR020220