Mamma Mia App for Perinatal Wellness

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to boost well-being during pregnancy and after giving birth through the "Mamma Mia" app. Participants will either receive usual prenatal care, use the app, or use the app with additional support from the study team. The researchers aim to determine if these digital tools can improve mental health and overall wellness during this crucial time. The trial suits pregnant women who are less than 25 weeks along, speak English, and have internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prenatal and postnatal care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Mamma Mia app and Mamma Mia Plus are safe for perinatal wellness?

Research has shown that the Mamma Mia program is safe for use during pregnancy and after childbirth. Studies have found that this app-based program can enhance well-being and reduce the risk of depression by 25% in at-risk women. It supports mental health during the perinatal phase, which includes the time before and after having a baby.

The program is grounded in positive psychology, aiming to boost happiness and well-being. It also incorporates metacognitive therapy, which changes unhelpful thinking patterns, and couples therapy. These approaches are generally safe and support mental health without causing harm.

The Mamma Mia Plus version offers occasional support from study staff, enhancing the app's benefits. No safety concerns have been reported with this added support.

Overall, both Mamma Mia and Mamma Mia Plus are well-tolerated, focusing on improving mental health and well-being safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mamma Mia app for perinatal wellness because it offers a unique approach to supporting mental health during and after pregnancy. Unlike traditional care, which relies on regular visits to healthcare providers, the Mamma Mia app provides continuous support through digital means, allowing for more accessible and personalized care. Additionally, the Mamma Mia Plus group includes occasional check-ins from study staff, offering an extra layer of support that could enhance the well-being of new and expectant mothers. This innovative approach could lead to better mental health outcomes during the perinatal period by integrating technology with standard care practices.

What evidence suggests that the Mamma Mia app is effective for perinatal wellness?

Research has shown that the Mamma Mia program, available to participants in this trial, might support mental health during and after pregnancy. Studies have found that this online program can reduce symptoms of depression in expecting and new mothers. The program employs techniques like positive thinking and metacognitive therapy, which help individuals understand and manage their thoughts. Early results suggest that women using Mamma Mia experienced better emotional well-being compared to those who did not use the program. Another group in this trial will use the Mamma Mia Plus version, which includes occasional support from study staff and might offer additional benefits. Overall, the evidence appears promising for enhancing wellness during and after pregnancy. ^{1 2 3 6 7}

Who Is on the Research Team?

Patricia Kinser, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for pregnant women under 25 weeks gestation, aged 18 or older, who speak English and can access internet/mobile-based programs. They must have a working phone number and email address.

Inclusion Criteria

I can use the internet on a device and have a working phone and email.

speak, read, and understand English;

I am pregnant and less than 25 weeks along.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the 'Mamma Mia' program regularly and may receive regular contact from study staff

6 months

Regular use of app, occasional contact from study staff

Follow-up

Participants are monitored for changes in depression, well-being, anxiety, and stress

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Mamma Mia
• Mamma Mia Plus

Trial Overview 'Mamma Mia' is an app designed to improve well-being during pregnancy and after birth. The study compares the standard 'Mamma Mia' program with 'Mamma Mia Plus,' which includes extra support from staff.

How Is the Trial Designed?

Group I: Mamma Mia group Experimental Treatment 1 Intervention

Usual prenatal/postpartum care plus use of the "Mamma Mia" program

Group II: Mamma Mia Plus group Experimental Treatment 2 Interventions

Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff

Group III: Usual care group Active Control 1 Intervention

Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

57% of postpartum patients reported using infant feeding tracker apps, with users more likely to have breastfed their infants, indicating that these apps may support breastfeeding practices.

Users of infant feeding tracker apps also engaged with more health apps overall, suggesting a trend towards increased health management among those who utilize these digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Feeding Tracker Applications: Cross-Sectional Analysis of Use. Dinour, LM.[2022]

Citations

1. journals.plos.org journals.plos.org/mentalhealth/article?id=10.1371/journal.pmen.0000138

Perceptions of the Mamma Mia program, an internet-based ... The Mamma Mia program is an internet-based intervention designed to prevent and/or intervene with perinatal mental health symptoms, such as depression symptoms.

2. mammamiastudy.org mammamiastudy.org/

Mamma Mia Study The "Mamma Mia" study is a NIH-funded study for perinatal health and well-being. We are recruiting thousands of women across the nation to participate.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3742405/

Mamma Mia: A Feasibility Study of a Web-Based ... Mamma Mia is based on positive psychology, metacognitive therapy, and couples therapy. It starts in gestational week 22, and lasts until 6 months after birth.

4. openicpsr.org openicpsr.org/openicpsr/project/207783/version/V1/view;jsessionid=D60A25D5D16477A638FE2998549DB7F3

"Mamma Mia" for Perinatal Health and Wellness 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6650775/

Mamma Mia – A randomized controlled trial of an internet ... The aim of this study was to assess the effectiveness of an automated internet intervention ('Mamma Mia') on perinatal depressive symptoms.

6. mammamiaapp.com mammamiaapp.com/for-healthcare-professionals

For healthcare professionals Mamma Mia is documented to increase subjective well-being during pre- and postpartum and to reduce the risk for perinatal depression by 25% in the risk group.

7. researchprotocols.org researchprotocols.org/2015/4/e120/PDF

An Internet-Based Intervention (Mamma Mia) for ... Background: As much as 10-15% of new mothers experience depression postpartum. An Internet-based intervention (Mamma. Mia) was developed with the primary ...