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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to postpartum, about 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to postpartum, about 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Depressive symptom severity
Secondary outcome measures
Change in anxiety
Change in stress
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
699 Previous Clinical Trials
22,884,845 Total Patients Enrolled
11 Trials studying Depression
6,302 Patients Enrolled for Depression
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,361 Total Patients Enrolled
23 Trials studying Depression
5,147 Patients Enrolled for Depression
Patricia Kinser, PhD, WHNP-BC, RN, FAANPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can understand, read and write English.I am pregnant and between 12 to 26 weeks along.Your doctor has not advised you to avoid physical activity.You have not practiced yoga once a week or more during your current pregnancy.You belong to a minority group (such as Black/African American, Hispanic/Latino, Native American) or have a low annual household income that qualifies you for Women, Infants, and Children [WIC] benefits in Virginia, or have an educational level of high school or lower.I am 18 years old or older.I am 18 years old or older.I am currently experiencing symptoms of depression.I am pregnant and between 12 to 26 weeks along.I am currently experiencing symptoms of depression.
Research Study Groups:
This trial has the following groups:- Group 1: Prenatal Education
- Group 2: Mindful Moms
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant enrollment rate in this clinical trial?
"That is correct. The page on clinicaltrials.gov reveals that this trial began recruiting patients on October 15th 2021 and has subsequently been updated as recently as October 13rd 2022. At present, 200 individuals need to be recruited from a single research centre."
Answered by AI
Who else is applying?
What state do they live in?
California
Virginia
How old are they?
18 - 65
What site did they apply to?
Virginia Commonwealth University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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