The Effects of Motherly on Postpartum Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Motherly app
* Behavioral: COMVC app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motherly App<br>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. | Behavioral: Motherly app<br>* 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.<br>|
| Active Comparator: COMVC App<br>Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring. | Behavioral: COMVC app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum depression, smartphone application, digital technology, maternal depression, mental health, mental disorder