"Mamma Mia" for Perinatal Health and Wellness

Perinatal Depression Clinical Trial

Official title:

"Mamma Mia" for Perinatal Health and Wellness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04300894
• Other study ID #: HM20017197
• Secondary ID: 1R01HD100395
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. The "usual care group", or

2. The "Mamma Mia group" (which is to use the "Mamma Mia" program regularly), or

3. 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:

1. Complete survey questions at entrance into the study.

2. Complete survey questions every few months (see schedule below).

Participants in the "Mamma Mia group" will be asked to do the following things:

1. Complete survey questions at entrance into the study.

2. 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.

3. Complete survey questions every few months.

Participants in the "Mamma Mia Plus group" will be asked to do the following things:

1. Complete survey questions at entrance into the study.

2. 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.

3. Complete survey questions every few months.

4. Participants will receive phone calls or emails or texts (depending upon participant preference) from study staff every few months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1952
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

Intervention

Device:
• Mamma Mia
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.

Other:
• Mamma Mia Plus
Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptom severity	measured by the Edinburgh Postpartum Depression Scale	Baseline to 6 months postpartum, about 11 months
Secondary	Change in subjective well-being	Measured using Satisfaction with Life Scale	Baseline to 6 months postpartum, about 11 months
Secondary	Change in anxiety	Measured by the State-Trait Anxiety Scale	Baseline to 6 months postpartum, about 11 months
Secondary	Change in stress	Measured by the Perceived Stress Scale	Baseline to 6 months postpartum, about 11 months