The Effects of Motherly on Postpartum Depression

Not Applicable

• Conditions: Postpartum Depression
• Interventions: Behavioral: COMVC app; Behavioral: Motherly app

• Registration Number: NCT05055674
• Lead Sponsor: University of Sao Paulo

Brief 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 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 Timeline

• Study First Submitted: 2021-08-31
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-03
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 264

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Depression symptoms	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)

Secondary Outcome Measures

Name	Time	Method
Parental Distress	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Attachment	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Anxiety symptoms	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	Change in mean total scores between intervention and control groups in the General Anxiety Disorder-7 (GAD-7)
Sleep quality	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	Change in mean total scores between intervention and control groups in the Single-item Sleep Quality Scale at Posttreatment (T1) and Follow-up (T2).
Parenting stress	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Parenting Competence	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Depression symptoms	Follow-up (T2) 2 months after baseline	Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS)
Quality of Life: Physical Health	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Quality of Life: Mental Health	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Parent-child Dysfunctional Interaction	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).
Difficult Child	Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline	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).