Perinatal DepressionNCT04300894
"Mamma Mia" for Perinatal Health and Wellness
A study testing Mamma Mia and Mamma Mia Plus in people with Perinatal Depression, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Mamma Mia and Mamma Mia Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,757 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Perinatal Depression
- Being tested
- Mamma Mia, Mamma Mia Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mamma MiaDevice
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 PlusOther
Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born. |
| Mamma Mia group | Experimental | Usual prenatal/postpartum care plus use of the "Mamma Mia" program Receives: Device: Mamma Mia |
| Mamma Mia Plus group | Experimental | Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff Receives: Device: Mamma Mia; Other: Mamma Mia Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months postpartum, about 11 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Baseline to 12 week post-postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 Oct 2020
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Patricia A Kinser, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300894
- Sponsor's protocol ID
- HM20017197
- Other IDs
- 1R01HD100395
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2020
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 41661763
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Mamma Mia" for Perinatal Health and Wellness
- ClinicalTrials.gov ID
- NCT04300894
- Acronym / sponsor ID
- HM20017197
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,757 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born. |
| Mamma Mia group | Experimental | Device: Mamma MiaUsual prenatal/postpartum care plus use of the "Mamma Mia" program |
| Mamma Mia Plus group | Experimental | Device: Mamma Mia, Other: Mamma Mia PlusUsual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mamma MiaUsers 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. | Device | Mamma Mia Plus group, Mamma Mia group |
| Mamma Mia PlusParticipants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months. | Other | Mamma Mia Plus group |
Primary outcome
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.
3 secondary outcomes
Change in Subjective Well-being
Time frame: Baseline to 6 months postpartum, about 11 months
Change in Stress
Time frame: Baseline to 6 months postpartum, about 11 months
Change in Anxiety
Time frame: Baseline to 12 week post-postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41661763Kinser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Kinser, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mamma Mia and Mamma Mia Plus in people with Perinatal Depression, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Symptom Severity (time frame: Baseline to 6 months postpartum, about 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.