The Effects of Motherly on Postpartum Depression

University of Sao Paulo

Status: Unknown

Conditions: Postpartum Depression

Treatments: Behavioral: COMVC app; Behavioral: Motherly app

Study type: Interventional

Funder types: Other

Identifiers

NCT05055674

OR2019-62903

Details and patient eligibility

About

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.

Full 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).

Enrollment: 264 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

264 participants in 2 patient groups

Motherly App

Experimental group

Description:

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.

Treatment:

Behavioral: Motherly app

COMVC App

Active Comparator group

Description:

Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring.

Treatment:

Behavioral: COMVC app