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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR020220 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Moms | Experimental | Weekly "Mindful Moms" sessions |
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| Prenatal Education | Active Comparator | Weekly prenatal education sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Moms | Behavioral | Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria: Does not meet the inclusion criteria above.
Pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kinser, PhD | Contact | 804-828-9140 | kinserpa@vcu.edu | |
| Christine Aubry, RN | Contact | aubrych@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Kinser, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37500008 | Derived | 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. Epub 2023 Jul 25. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064186 | Prenatal Education |
| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Prenatal Education | Behavioral | 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). |
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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 |
| D005159 |
| Health Care Facilities Workforce and Services |