Back to resultsMindful Moms Randomized Control Trial
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Moms
Prenatal Education
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring pregnancy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria: Does not meet the inclusion criteria above.
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindful Moms
Prenatal Education
Arm Description
Weekly "Mindful Moms" sessions
Weekly prenatal education sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in anxiety
Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.
Change in stress
Stress will be assessed using the JHP Contextualized Stress Measure. The JHP measures the stressors and coping mechanisms to which women are exposed to, with a range of score from 25-125 (higher score indicates higher stress)
Full Information
NCT ID
NCT04886856
First Posted
May 11, 2021
Last Updated
October 10, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04886856
Brief Title
Mindful Moms Randomized Control Trial
Official Title
Mindful Moms Randomized Control Trial Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindful Moms
Arm Type
Experimental
Arm Description
Weekly "Mindful Moms" sessions
Arm Title
Prenatal Education
Arm Type
Active Comparator
Arm Description
Weekly prenatal education sessions
Intervention Type
Behavioral
Intervention Name(s)
Mindful Moms
Intervention Description
Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.
Intervention Type
Behavioral
Intervention Name(s)
Prenatal Education
Intervention Description
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 Outcome Measure Information:
Title
Change in Depressive symptom severity
Description
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.
Time Frame
Baseline to postpartum, about 8 months
Secondary Outcome Measure Information:
Title
Change in anxiety
Description
Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.
Time Frame
Baseline to postpartum, about 8 months
Title
Change in stress
Description
Stress will be assessed using the JHP Contextualized Stress Measure. The JHP measures the stressors and coping mechanisms to which women are exposed to, with a range of score from 25-125 (higher score indicates higher stress)
Time Frame
Baseline to postpartum, about 8 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria: Does not meet the inclusion criteria above.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Kinser, PhD
Phone
804-828-9140
Email
kinserpa@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Aubry, RN
Email
aubrych@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Kinser, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindful Moms Randomized Control Trial
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