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Completed

NCT Number: NCT04886856

Mindful Moms Randomized Control Trial

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant woman at 12-26 weeks gestation at baseline visit;
  • ≥age 18;
  • current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS) or a score ≥2 on the PHQ-2;
  • able to read, write, and understand English or Spanish;
  • 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.

Treatment and study plan

Mindful Moms

Behavioral

Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.

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).

Primary outcomes

  1. Change in Depressive symptom severity

    Time frame: 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 outcomes

  1. Change in anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Mindful Moms Randomized Control Trial Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 14, 2021
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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