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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motherly app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression symptoms | Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1) | Posttreatment (T1) 1 month after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Depression symptoms | Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) | Follow-up (T2) 2 months after baseline |
| Anxiety symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Activation and avoidance behaviors | Change in mean scores between intervention and control groups in the The Behavioral Activation for Depression Scale-Short Form (BADS-SF) scale. | Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline |
| Reinforcement probability and environmental suppression |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Fatori, PhD | Contact | +55 11 96162-6183 | daniel.fatori@gmail.com | |
| Adriana Argeu, Psychologist | Contact | +55 11 98603-9059 | adrianaargeu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guilherme V Polanczyk, MD, PhD | Professor | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650773 | Background | 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. | |
| 21426237 | Background | Wang 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. |
| Label | URL |
|---|---|
| Official website of the Motherly app | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 22, 2023 | |
| Reset | Jun 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 22, 2023 | Jun 14, 2024 |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D000092862 | Psychological Well-Being |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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Participants will be aware of the intervention received, as well as investigators and professionals responsible for monitoring app usage during the study. The Outcome assessor will be blind to randomization status.
|
| COMVC app | Behavioral | 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. |
|
Change in mean total scores between intervention and control groups in the General Anxiety Disorder-7 (GAD-7)
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline |
Change in mean scores between intervention and control groups in the Reward Probability Index (RPI) scale. |
| Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline |
| Response to treatment | Comparison between intervention and control groups according to two categories: Very much improved, Much improved, Minimally improved vs. No change, Minimally worse, Much worse, Very much worse, in the Clinical Global Impression Index (CGI) scale. | Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline |
| 32408866 | Background | Jacques 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. |
| 25553403 | Background | Matijasevich 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. |
| 33757591 | Background | Zuccolo 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. |
| 31815193 | Background | Weisel 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. |
| 17952250 | Background | Santos 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. |
| 26456404 | Background | Goncalves 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. |
| 29387878 | Background | Netsi 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. |
| 22407278 | Background | Kingston 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. |
| 20921117 | Background | Grote 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. |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |