Mindful Moms Randomized Control Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindful Moms Randomized Control Trial Study

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Mindful Moms
* Behavioral: Prenatal Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Moms<br>Weekly Mindful Moms sessions | Behavioral: Mindful Moms<br>* Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.<br>|
| Active Comparator: Prenatal Education<br>Weekly prenatal education sessions | Behavioral: Prenatal Education<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive symptom severity | 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. | Baseline to postpartum, about 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety | Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety. | Baseline to postpartum, about 8 months | 
| Change in stress | Stress will be assessed using the JHP Contextualized Stress Measure. The JHP measures the stressors and coping mechanisms to which women are exposed to, with a range of score from 25-125 (higher score indicates higher stress) | Baseline to postpartum, about 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy