Mindful Moms Randomized Control Trial

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Behavioral: Prenatal Education; Behavioral: Mindful Moms

• Registration Number: NCT04886856
• Lead Sponsor: Virginia Commonwealth University

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.

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 Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-14
• Study Start: 2021-10-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-06
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prenatal Education	Prenatal Education	Weekly prenatal education sessions
Mindful Moms	Mindful Moms	Weekly "Mindful Moms" sessions

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States