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Mindfulness Training for Depression in Pregnancy

N/A
Recruiting
Led By Patricia Kinser, PhD, WHNP-BC, RN, FAAN
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant woman at 12-26 weeks gestation at baseline visit
≥Age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to postpartum, about 8 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether "Mindful Moms" can help pregnant women with depressive symptoms, compared to education workshops.

Who is the study for?
This trial is for pregnant women between 12-26 weeks gestation, over 18 years old, with depressive symptoms but not in regular yoga practice. It's aimed at those who haven't been advised against physical activity and can understand English. Priority is given to minorities or those with lower income/education.
What is being tested?
The 'Mindful Moms' program aims to improve mood and health in pregnant women with depression. This study compares the effects of this mindfulness-based intervention against group prenatal education workshops.
What are the potential side effects?
Since the interventions involve mindfulness practices and educational workshops, significant side effects are unlikely. However, participants may experience emotional discomfort when discussing personal topics or mild physical strain during activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and between 12 to 26 weeks along.
Select...
I am 18 years old or older.
Select...
I am currently experiencing symptoms of depression.
Select...
I am pregnant and between 12 to 26 weeks along.
Select...
I am currently experiencing symptoms of depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to postpartum, about 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to postpartum, about 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Depressive symptom severity
Secondary study objectives
Change in anxiety
Change in stress

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful MomsExperimental Treatment1 Intervention
Weekly "Mindful Moms" sessions
Group II: Prenatal EducationActive Control1 Intervention
Weekly prenatal education sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Moms
2011
N/A
~210

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,298 Total Patients Enrolled
11 Trials studying Depression
6,302 Patients Enrolled for Depression
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,379 Total Patients Enrolled
24 Trials studying Depression
5,452 Patients Enrolled for Depression
Patricia Kinser, PhD, WHNP-BC, RN, FAANPrincipal InvestigatorVirginia Commonwealth University

Media Library

Mindful Moms Clinical Trial Eligibility Overview. Trial Name: NCT04886856 — N/A
Depression Research Study Groups: Prenatal Education, Mindful Moms
Depression Clinical Trial 2023: Mindful Moms Highlights & Side Effects. Trial Name: NCT04886856 — N/A
Mindful Moms 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886856 — N/A
~65 spots leftby Jun 2026
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