Postpartum DepressionNCT05055674
The Effects of Motherly on Postpartum Depression
A study testing Motherly app and COMVC app in people with Postpartum Depression, run by University of Sao Paulo.
Trial summary
Investigators will be test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Motherly app and COMVC app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who had given birth to a live baby in the past 12 months;
- Age between 18-40 years;
- Edinburgh Postnatal Depression Scale (EPDS) total score ≥ 10;
- Depression symptoms present in the past 2 weeks;
- Being literate;
- Owing an Android or iPhone smartphone for personal use.
Who cannot join
- Intellectual, visual, or auditory deficiency;
- Chronic diseases that prevent using smartphones or understanding how to use the apps;
- Severe and/or chronic mental health diagnosis (schizophrenia or bipolar disorder).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression
Investigators will be test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Participants will be randomly allocated to receive the Motherly app (intervention), or COMVC (active control), a smartphone app that delivers only psychoeducational content related to general mental health.
Read the detailed description
The postpartum period is strongly associated with increased risk for depression, with estimates of approximately 19% of women affected by the disorder. Psychosocial interventions such as home visiting programs and well-established psychological therapies are efficient to treat this condition but require a significant number of qualified trained professionals. However, financial and human resources to meet these demands are scarce in developing countries such as Brazil. Therefore, interventions delivered via electronic devices such as smartphones might fill this gap. Our objective is to test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Two-hundred and sixty-four (N=264) 18-40-years-old women with postpartum depression will be to one of two groups: (1) intervention, which will have access to the Motherly app; or (2) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content on general mental health (COMVC means "With You" in Brazilian Portuguese). Duration of treatment will be four weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), end (post treatment, T1), and 1 month after treatment completion (follow-up, T2).
- Conditions
- Postpartum Depression
- Being tested
- Motherly app, COMVC app
- Keywords
- postpartum depression, smartphone application, digital technology, maternal depression, mental health, mental disorder
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motherly appBehavioural
The Motherly app is organized in four different modules: 1) Library: a collection of brief texts on several topics related to health and pregnancy, 2) Health: journeys with varying degrees of interactivity designed to teach and engage participants in well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene techniques), 3) Pregnancy and motherhood: a module to help mothers keep track of their health care visits, medical exams, and their childrens' development, and 4) Profile: a module allowing participants to keep track of activities and goals completed in the Health module journeys, and to assess depression and anxiety symptoms with brief questionnaires, with results displayed graphically in a timeline and in the the form of short feedback texts.
COMVC appBehavioural
The COMVC displays over 30 brief psychoeducational videos on several topics related to general mental health, such as depression, anxiety, stress, sleep, problem solving techniques, among others. Psychoeducation is limited to video only (no interactivity). The content of these videos was developed by clinicians, researchers, and professors from the Psychiatry Department of the Medical School of the University of Sao Paulo and from the Federal University of Rio Grande do Sul. Mental health monitoring is delivered by means of brief questionnaires assessing depression and anxiety symptoms, which can be filled at users' discretion. Users' responses are displayed graphically in a timeline and they receive short feedback texts based on assessment results.
| Study group | Role | What they receive |
|---|---|---|
| Motherly App | Experimental | Participants in this arm will have access to Motherly, a smartphone app that is designed to promote life habits that have been shown to improve depression and mental health in mothers. Receives: Behavioral: Motherly app |
| COMVC App | Active comparator | Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring. Receives: Behavioral: COMVC app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1)
Measured: Posttreatment (T1) 1 month after baseline
Secondary outcomes (11)
Depression symptoms
Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS)
Measured: Follow-up (T2) 2 months after baseline
Anxiety symptoms
Change in mean total scores between intervention and control groups in the General Anxiety Disorder-7 (GAD-7)
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Sleep quality
Change in mean total scores between intervention and control groups in the Single-item Sleep Quality Scale at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Physical Health
Change in "Physical Health Quality of Life" mean scores between intervention and control groups in the 12-item health survey (SF-12) at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Mental Health
Change in "Mental Health Quality of Life" mean scores between intervention and control groups in the 12-item health survey (SF-12) at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting stress
Change in "Total Stress" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parental Distress
Change in "Parental Distress" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parent-child Dysfunctional Interaction
Change in "Parent-child Dysfunctional Interaction" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Difficult Child
Change in "Difficult Child" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Attachment
Change in "Attachment" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting Competence
Change in "Competence" mean scores between intervention and control groups in the Parenting Stress Index (PSI) Short Form at Posttreatment (T1) and Follow-up (T2).
Measured: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups: a) intervention, which will have access to the Motherly app; or b) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
- Investigators
- Guilherme V Polanczyk, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055674
- Sponsor's protocol ID
- OR2019-62903
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gelaye B, Rondon MB, Araya R, Williams MA. Epidemiology of maternal depression, risk factors, and child outcomes in low-income and middle-income countries. Lancet Psychiatry. 2016 Oct;3(10):973-982. doi: 10.1016/S2215-0366(16)30284-X. Epub 2016 Sep 17.
PubMed 27650773Wang L, Wu T, Anderson JL, Florence JE. Prevalence and risk factors of maternal depression during the first three years of child rearing. J Womens Health (Larchmt). 2011 May;20(5):711-8. doi: 10.1089/jwh.2010.2232. Epub 2011 Mar 22.
PubMed 21426237Jacques N, Mesenburg MA, Matijasevich A, Domingues MR, Bertoldi AD, Stein A, Silveira MF. Trajectories of maternal depressive symptoms from the antenatal period to 24-months postnatal follow-up: findings from the 2015 Pelotas birth cohort. BMC Psychiatry. 2020 May 14;20(1):233. doi: 10.1186/s12888-020-02533-z.
PubMed 32408866Matijasevich A, Murray J, Cooper PJ, Anselmi L, Barros AJ, Barros FC, Santos IS. Trajectories of maternal depression and offspring psychopathology at 6 years: 2004 Pelotas cohort study. J Affect Disord. 2015 Mar 15;174:424-31. doi: 10.1016/j.jad.2014.12.012. Epub 2014 Dec 13.
PubMed 25553403Zuccolo PF, Xavier MO, Matijasevich A, Polanczyk G, Fatori D. A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial. Trials. 2021 Mar 23;22(1):227. doi: 10.1186/s13063-021-05179-8.
PubMed 33757591Weisel KK, Fuhrmann LM, Berking M, Baumeister H, Cuijpers P, Ebert DD. Standalone smartphone apps for mental health-a systematic review and meta-analysis. NPJ Digit Med. 2019 Dec 2;2:118. doi: 10.1038/s41746-019-0188-8. eCollection 2019.
PubMed 31815193Santos IS, Matijasevich A, Tavares BF, Barros AJ, Botelho IP, Lapolli C, Magalhaes PV, Barbosa AP, Barros FC. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in a sample of mothers from the 2004 Pelotas Birth Cohort Study. Cad Saude Publica. 2007 Nov;23(11):2577-88. doi: 10.1590/s0102-311x2007001100005.
PubMed 17952250Goncalves H, Pearson RM, Horta BL, Gonzalez-Chica DA, Castilho E, Damiani M, Lima RC, Gigante DP, Barros FC, Stein A, Victora CG. Maternal depression and anxiety predicts the pattern of offspring symptoms during their transition to adulthood. Psychol Med. 2016 Jan;46(2):415-24. doi: 10.1017/S0033291715001956. Epub 2015 Oct 12.
PubMed 26456404Netsi E, Pearson RM, Murray L, Cooper P, Craske MG, Stein A. Association of Persistent and Severe Postnatal Depression With Child Outcomes. JAMA Psychiatry. 2018 Mar 1;75(3):247-253. doi: 10.1001/jamapsychiatry.2017.4363.
PubMed 29387878Kingston D, Tough S, Whitfield H. Prenatal and postpartum maternal psychological distress and infant development: a systematic review. Child Psychiatry Hum Dev. 2012 Oct;43(5):683-714. doi: 10.1007/s10578-012-0291-4.
PubMed 22407278Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010 Oct;67(10):1012-24. doi: 10.1001/archgenpsychiatry.2010.111.
PubMed 20921117Borja T, Fonseca Zuccolo P, Seda L, Matijasevich A, Vanoni Polanczyk G, Fatori D. Moderators, mediators, and components of a standalone smartphone application for postpartum depression: secondary analysis of a randomized controlled trial. Arch Womens Ment Health. 2026 May 22;29(3):85. doi: 10.1007/s00737-026-01705-2.
PubMed 42171809
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression
- ClinicalTrials.gov ID
- NCT05055674
- Acronym / sponsor ID
- OR2019-62903
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, smartphone application, digital technology, maternal depression, mental health, mental disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will be test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Participants will be randomly allocated to receive the Motherly app (intervention), or COMVC (active control), a smartphone app that delivers only psychoeducational content related to general mental health.
Detailed description
The postpartum period is strongly associated with increased risk for depression, with estimates of approximately 19% of women affected by the disorder. Psychosocial interventions such as home visiting programs and well-established psychological therapies are efficient to treat this condition but require a significant number of qualified trained professionals. However, financial and human resources to meet these demands are scarce in developing countries such as Brazil. Therefore, interventions delivered via electronic devices such as smartphones might fill this gap. Our objective is to test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Two-hundred and sixty-four (N=264) 18-40-years-old women with postpartum depression will be to one of two groups: (1) intervention, which will have access to the Motherly app; or (2) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content on general mental health (COMVC means "With You" in Brazilian Portuguese). Duration of treatment will be four weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), end (post treatment, T1), and 1 month after treatment completion (follow-up, T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups: a) intervention, which will have access to the Motherly app; or b) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content.
| Arm | Type | Receives |
|---|---|---|
| Motherly App | Experimental | Behavioral: Motherly appParticipants in this arm will have access to Motherly, a smartphone app that is designed to promote life habits that have been shown to improve depression and mental health in mothers. |
| COMVC App | Active comparator | Behavioral: COMVC appParticipants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women who had given birth to a live baby in the past 12 months;
- Age between 18-40 years;
- Edinburgh Postnatal Depression Scale (EPDS) total score ≥ 10;
- Depression symptoms present in the past 2 weeks;
- Being literate;
Key exclusion criteria (3 listed)
- Intellectual, visual, or auditory deficiency;
- Chronic diseases that prevent using smartphones or understanding how to use the apps;
- Severe and/or chronic mental health diagnosis (schizophrenia or bipolar disorder).
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 |
|---|---|---|
| Motherly appThe Motherly app is organized in four different modules: 1) Library: a collection of brief texts on several topics related to health and pregnancy, 2) Health: journeys with varying degrees of interactivity designed to teach and engage participants in well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene techniques), 3) Pregnancy and motherhood: a module to help mothers keep track of their health care visits, medical exams, and their childrens' development, and 4) Profile: a module allowing participants to keep track of activities and goals completed in the Health module journeys, and to assess depression and anxiety symptoms with brief questionnaires, with results displayed graphically in a timeline and in the the form of short feedback texts. | Behavioural | Motherly App |
| COMVC appThe COMVC displays over 30 brief psychoeducational videos on several topics related to general mental health, such as depression, anxiety, stress, sleep, problem solving techniques, among others. Psychoeducation is limited to video only (no interactivity). The content of these videos was developed by clinicians, researchers, and professors from the Psychiatry Department of the Medical School of the University of Sao Paulo and from the Federal University of Rio Grande do Sul. Mental health monitoring is delivered by means of brief questionnaires assessing depression and anxiety symptoms, which can be filled at users' discretion. Users' responses are displayed graphically in a timeline and they receive short feedback texts based on assessment results. | Behavioural | COMVC App |
Primary outcome
Depression symptoms
Time frame: Posttreatment (T1) 1 month after baseline
Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1)
11 secondary outcomes
Depression symptoms
Time frame: Follow-up (T2) 2 months after baseline
Anxiety symptoms
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Sleep quality
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Physical Health
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Mental Health
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting stress
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parental Distress
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parent-child Dysfunctional Interaction
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Difficult Child
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Attachment
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting Competence
Time frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 27650773Gelaye B, Rondon MB, Araya R, Williams MA. Epidemiology of maternal depression, risk factors, and child outcomes in low-income and middle-income countries. Lancet Psychiatry. 2016 Oct;3(10):973-982. doi: 10.1016/S2215-0366(16)30284-X. Epub 2016 Sep 17.
- Background: PubMed 21426237Wang L, Wu T, Anderson JL, Florence JE. Prevalence and risk factors of maternal depression during the first three years of child rearing. J Womens Health (Larchmt). 2011 May;20(5):711-8. doi: 10.1089/jwh.2010.2232. Epub 2011 Mar 22.
- Background: PubMed 32408866Jacques N, Mesenburg MA, Matijasevich A, Domingues MR, Bertoldi AD, Stein A, Silveira MF. Trajectories of maternal depressive symptoms from the antenatal period to 24-months postnatal follow-up: findings from the 2015 Pelotas birth cohort. BMC Psychiatry. 2020 May 14;20(1):233. doi: 10.1186/s12888-020-02533-z.
- Background: PubMed 25553403Matijasevich A, Murray J, Cooper PJ, Anselmi L, Barros AJ, Barros FC, Santos IS. Trajectories of maternal depression and offspring psychopathology at 6 years: 2004 Pelotas cohort study. J Affect Disord. 2015 Mar 15;174:424-31. doi: 10.1016/j.jad.2014.12.012. Epub 2014 Dec 13.
- Background: PubMed 33757591Zuccolo PF, Xavier MO, Matijasevich A, Polanczyk G, Fatori D. A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial. Trials. 2021 Mar 23;22(1):227. doi: 10.1186/s13063-021-05179-8.
- Background: PubMed 31815193Weisel KK, Fuhrmann LM, Berking M, Baumeister H, Cuijpers P, Ebert DD. Standalone smartphone apps for mental health-a systematic review and meta-analysis. NPJ Digit Med. 2019 Dec 2;2:118. doi: 10.1038/s41746-019-0188-8. eCollection 2019.
- Background: PubMed 17952250Santos IS, Matijasevich A, Tavares BF, Barros AJ, Botelho IP, Lapolli C, Magalhaes PV, Barbosa AP, Barros FC. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in a sample of mothers from the 2004 Pelotas Birth Cohort Study. Cad Saude Publica. 2007 Nov;23(11):2577-88. doi: 10.1590/s0102-311x2007001100005.
- Background: PubMed 26456404Goncalves H, Pearson RM, Horta BL, Gonzalez-Chica DA, Castilho E, Damiani M, Lima RC, Gigante DP, Barros FC, Stein A, Victora CG. Maternal depression and anxiety predicts the pattern of offspring symptoms during their transition to adulthood. Psychol Med. 2016 Jan;46(2):415-24. doi: 10.1017/S0033291715001956. Epub 2015 Oct 12.
- Background: PubMed 29387878Netsi E, Pearson RM, Murray L, Cooper P, Craske MG, Stein A. Association of Persistent and Severe Postnatal Depression With Child Outcomes. JAMA Psychiatry. 2018 Mar 1;75(3):247-253. doi: 10.1001/jamapsychiatry.2017.4363.
- Background: PubMed 22407278Kingston D, Tough S, Whitfield H. Prenatal and postpartum maternal psychological distress and infant development: a systematic review. Child Psychiatry Hum Dev. 2012 Oct;43(5):683-714. doi: 10.1007/s10578-012-0291-4.
- Background: PubMed 20921117Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010 Oct;67(10):1012-24. doi: 10.1001/archgenpsychiatry.2010.111.
- Derived from this study: PubMed 42171809Borja T, Fonseca Zuccolo P, Seda L, Matijasevich A, Vanoni Polanczyk G, Fatori D. Moderators, mediators, and components of a standalone smartphone application for postpartum depression: secondary analysis of a randomized controlled trial. Arch Womens Ment Health. 2026 May 22;29(3):85. doi: 10.1007/s00737-026-01705-2.
- Official website of the Motherly appLink provided by the sponsor.
- 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.
Guilherme V Polanczyk, MD, PhD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Motherly app and COMVC app in people with Postpartum Depression, run by University of Sao Paulo.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Fatori, PhD (+55 11 96162-6183, daniel.fatori@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: Posttreatment (T1) 1 month after baseline). 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 NCT05055674, which also lists 12 linked publications.
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 24 Sep 2021.