Mindful Moms Randomized Control Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindful Moms Weekly "Mindful Moms" sessions |
Behavioral: Mindful Moms
Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.
|
| Active Comparator: Prenatal Education Weekly prenatal education sessions |
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).
|
Outcome Measures
Primary Outcome Measures
- Change in Depressive symptom severity [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 Outcome Measures
- Change in anxiety [Baseline to postpartum, about 8 months]
Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.
- Change in stress [Baseline to postpartum, about 8 months]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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pregnant woman at 12-26 weeks gestation at baseline visit;
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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;
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≥age 18;
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current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
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able to read, write, and understand English;
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has not been told by a healthcare provider to avoid physical activity;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Patricia Kinser, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20021720
- 1R01NR020220