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Completed

NCT Number: NCT04300894

"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.

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Key information

Conditions

Perinatal Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mamma Mia

Device

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.

Mamma Mia Plus

Other

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

Primary outcomes

  1. Change in Depression Symptom Severity

    Time frame: Baseline to 6 months postpartum, about 11 months

    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.

Secondary outcomes

  1. Change in Subjective Well-being

    Time frame: Baseline to 6 months postpartum, about 11 months

    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.

  2. Change in Stress

    Time frame: Baseline to 6 months postpartum, about 11 months

    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.

  3. Change in Anxiety

    Time frame: Baseline to 12 week post-postpartum

    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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2020
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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