NCT04886856

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
1mo left

Started Oct 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2021Jun 2026

First Submitted

Initial submission to the registry

May 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

May 11, 2021

Last Update Submit

October 20, 2025

Conditions

Depression

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in anxiety

    Baseline to postpartum, about 8 months

  • Change in stress

    Baseline to postpartum, about 8 months

Study Arms (2)

Mindful Moms

EXPERIMENTAL

Weekly "Mindful Moms" sessions

Behavioral: Mindful Moms

Prenatal Education

ACTIVE COMPARATOR

Weekly prenatal education sessions

Behavioral: Prenatal Education

Interventions

Mindful MomsBEHAVIORAL

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

Mindful Moms
Prenatal EducationBEHAVIORAL

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).

Prenatal Education

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37500008DERIVED

MeSH Terms

Conditions

Depression

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Patricia Kinser, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Kinser, PhD

CONTACT

804-828-9140kinserpa@vcu.edu

Christine Aubry, RN

CONTACT

aubrych@vcu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 14, 2021

Study Start

October 15, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)