"Mamma Mia" for Perinatal Health and Wellness

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Depression
• Intervention / Treatment: Device: Mamma Mia; Other: Mamma Mia Plus

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 1757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Experimental: Mamma Mia group; Usual prenatal/postpartum care plus use of the "Mamma Mia" program	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.
Experimental: Mamma Mia Plus group; Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Symptom Severity	Measured by the Edinburgh Postpartum Depression Scale (EPDS), it uses a 10-item self-report questionnaire that screens for symptoms of depression and anxiety during pregnancy and the first year postpartum. Mothers are asked to select the answer that comes closest to how they have felt over the past 7 days. Each of the 10 questions is scored from 0 to 3, yielding a maximum total score of 30. Some questions (items 3, 5, 6, 7, 8, 9, 10) are reverse-scored (e.g., 3, 2, 1, 0 instead of 0, 1, 2, 3). 0-9 (minimal to no symptoms): Indicates some distress that is likely short-lived. Monitoring is usually recommended if symptoms persist. 10-12 (Mild Distress): Indicates discomforting symptoms. Healthcare providers often suggest a repeat screen in 2 weeks. 13 or higher (Probable depression): Scores at or above this threshold typically signify a positive screen. Further clinical evaluation and potential referral to a mental health professional are strongly recommended.	Baseline to 6 months postpartum, about 11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Subjective Well-being	Measured using Satisfaction with Life Scale (SWLS). It consists of five items, and each is scored on a Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), and is presented in raw scores, with a total score range of 5 to 35. Higher scores indicate greater life satisfaction.	Baseline to 6 months postpartum, about 11 months
Change in Stress	Measured by the Perceived Stress Scale (PSS) which is a classic, widely used psychological questionnaire that evaluates the degree to which an individual views their life as unpredictable, uncontrollable, and overloaded over the past month. Scores on the 10-item version range from 0 to 40: 0-13 Low perceived stress, 14-26: Moderate perceived stress, and 27-40 High perceived stress.	Baseline to 6 months postpartum, about 11 months
Change in Anxiety	Measured by the Perinatal Anxiety Screening Scale (PASS). The scale runs from 0-93, severity of perinatal anxiety symptoms are considered within the following score ranges: minimal anxiety (score 0-20); mild-moderate anxiety (score 21-41); and severe anxiety (score 41-93). A score of 26 or higher on the 31-item Perinatal Anxiety Screening Scale (PASS) is the standard clinical cut-off. A score at or above this threshold indicates the individual is at high risk for presenting with an anxiety disorder and may require further clinical evaluation. A score lower than 26 indicates minimal or mild anxiety and would not indicate further clinical evaluation. This was not administered in the late postpartum data collection timepoint, due to the lack of relevance of many items to that timepoint. The scale runs from 0-93	Baseline to 12 week post-postpartum

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Patricia A Kinser, PhD, Virginia Commonwealth University

Publications and helpful links

General Publications

• Kinser PA, Moyer S, Jones HA, Jallo N, Popoola A, Thacker L, Russell S, Olavesen ES, Sundrehagen T, Hare MM, Xia B, Garthus-Niegel S, Haga S, Drozd F. Perceptions of the Mamma Mia program, an internet-based prevention strategy for perinatal depression symptoms. PLOS Ment Health. 2025 Apr 3;2(4):e0000138. doi: 10.1371/journal.pmen.0000138. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: HM20017197; 1R01HD100395 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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