"Mamma Mia" for Perinatal Health and Wellness
Primary Purpose
Perinatal Depression
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mamma Mia
Mamma Mia Plus
Sponsored by

About this trial
This is an interventional prevention trial for Perinatal Depression
Eligibility Criteria
Inclusion Criteria:
- pregnant woman <25 weeks gestation;
- age 18 or older;
- speak, read, and understand English;
- have the ability to access an internet/mobile-based program (via computer, tablet, or smartphone), and have a working phone number and a working email address.
Exclusion Criteria:
• none
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Usual care group
Mamma Mia group
Mamma Mia Plus group
Arm Description
Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
Outcomes
Primary Outcome Measures
Change in depression symptom severity
measured by the Edinburgh Postpartum Depression Scale
Secondary Outcome Measures
Change in subjective well-being
Measured using Satisfaction with Life Scale
Change in anxiety
Measured by the State-Trait Anxiety Scale
Change in stress
Measured by the Perceived Stress Scale
Full Information
NCT ID
NCT04300894
First Posted
March 6, 2020
Last Updated
October 10, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04300894
Brief Title
"Mamma Mia" for Perinatal Health and Wellness
Official Title
"Mamma Mia" for Perinatal Health and Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research study is to find out about ways to enhance well-being during pregnancy and the postpartum period (after the baby is born). The "Mamma Mia" program and/or guided support from study staff ("Mamma Mia Plus") may be helpful because the app provides skills and information related to many important topics during and after pregnancy. This study will allow us to learn more about whether and how the program is helpful to women.
Detailed Description
This study will compare findings in women who do not use the program ("usual care group") versus women who use the program ("Mamma Mia group") versus women who use the program and receive regular contact from study staff ("Mamma Mia Plus"). The study will assess well-being, depression, stress, and anxiety as well as whether certain factors (for example, women's age, type of healthcare provider, amount of social support) are related to the effects of the program. For women randomized to use the program, the study will also collect information about the time spent using it and the modules completed.
Usual prenatal and postpartum care involves regular visits with participant's women's health care provider while pregnant and after the baby is born. In this study, participants will receive continue receiving usual care. In addition, participants will be randomly assigned (like the flip of a coin) to participate in one of the following groups:
The "usual care group", or
The "Mamma Mia group" (which is to use the "Mamma Mia" program regularly), or
The "Mamma Mia Plus group" (which is to use the program regularly plus receive regular contact with study staff).
There is a 1 chance in 3 of being assigned to each of the three groups. participants have an equal chance of being assigned to any one of the groups.
Participants in the "usual care group" will be asked to do the following things:
Complete survey questions at entrance into the study.
Complete survey questions every few months (see schedule below).
Participants in the "Mamma Mia group" will be asked to do the following things:
Complete survey questions at entrance into the study.
Use the "Mamma Mia" program on a regular basis (on average: weekly for about 10 minutes) from entering study until six months postpartum; participants will receive an email reminder to complete modules when they should be completed.
Complete survey questions every few months.
Participants in the "Mamma Mia Plus group" will be asked to do the following things:
Complete survey questions at entrance into the study.
Use the "Mamma Mia" program on a regular basis (on average: weekly for about 10 minutes) from entrance into the study until six months postpartum.
Complete survey questions every few months.
Participants will receive phone calls or emails or texts (depending upon participant preference) from study staff every few months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1952 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Arm Title
Mamma Mia group
Arm Type
Experimental
Arm Description
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
Arm Title
Mamma Mia Plus group
Arm Type
Experimental
Arm Description
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
Intervention Type
Device
Intervention Name(s)
Mamma Mia
Intervention Description
Users of the Mamma Mia program progress through the intervention in a sequence of modules.
Every day that a module should be completed, you will receive a notification with a reminder to access the program. By clicking on the reminder, you can access that particular day's session content. Modules involve a variety of information and activities; for example, there are guided mindfulness practices, information on breastfeeding, instructional videos on how to interpret your baby's cries, and discussions on how to have effective discussions with your partner or healthcare provider about your needs.
Intervention Type
Other
Intervention Name(s)
Mamma Mia Plus
Intervention Description
Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.
Primary Outcome Measure Information:
Title
Change in depression symptom severity
Description
measured by the Edinburgh Postpartum Depression Scale
Time Frame
Baseline to 6 months postpartum, about 11 months
Secondary Outcome Measure Information:
Title
Change in subjective well-being
Description
Measured using Satisfaction with Life Scale
Time Frame
Baseline to 6 months postpartum, about 11 months
Title
Change in anxiety
Description
Measured by the State-Trait Anxiety Scale
Time Frame
Baseline to 6 months postpartum, about 11 months
Title
Change in stress
Description
Measured by the Perceived Stress Scale
Time Frame
Baseline to 6 months postpartum, about 11 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant woman <25 weeks gestation;
age 18 or older;
speak, read, and understand English;
have the ability to access an internet/mobile-based program (via computer, tablet, or smartphone), and have a working phone number and a working email address.
Exclusion Criteria:
• none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
"Mamma Mia" for Perinatal Health and Wellness
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