Mindful Moms Randomized Control Trial

NCT04886856 | Completed

• 2 other identifiers: HM200217201R01NR020220
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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 (1)

• Change in anxiety

  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 Moms BEHAVIORAL

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

Mindful Moms

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).

Prenatal Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

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: 37500008 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Education as Topic; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Patricia Kinser, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

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: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)