The Effects of Motherly on Postpartum Depression

University of Sao Paulo264 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Interventions

Motherly appBEHAVIORAL

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 appBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Depression symptoms

Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1)

Time frame: Posttreatment (T1) 1 month after baseline

Secondary Outcomes

Depression symptoms

Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS)

Time frame: 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)