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The Effects of Motherly on Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motherly app
COMVC app
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring postpartum depression, smartphone application, digital technology, maternal depression, mental health, mental disorder

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Motherly App

    COMVC App

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Depression symptoms
    Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS)
    Anxiety symptoms
    Change in mean total scores between intervention and control groups in the General Anxiety Disorder-7 (GAD-7)
    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).
    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).
    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).
    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).
    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).
    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).
    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).
    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).
    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).

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    September 14, 2021
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05055674
    Brief Title
    The Effects of Motherly on Postpartum Depression
    Official Title
    Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Depression
    Keywords
    postpartum depression, smartphone application, digital technology, maternal depression, mental health, mental disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    264 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motherly App
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    COMVC App
    Arm Type
    Active Comparator
    Arm Description
    Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motherly app
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    COMVC app
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Depression symptoms
    Description
    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 Outcome Measure Information:
    Title
    Depression symptoms
    Description
    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
    Title
    Anxiety symptoms
    Description
    Change in mean total scores between intervention and control groups in the General Anxiety Disorder-7 (GAD-7)
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Sleep quality
    Description
    Change in mean total scores between intervention and control groups in the Single-item Sleep Quality Scale at Posttreatment (T1) and Follow-up (T2).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Quality of Life: Physical Health
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Quality of Life: Mental Health
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Parenting stress
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Parental Distress
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Parent-child Dysfunctional Interaction
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Difficult Child
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Attachment
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Parenting Competence
    Description
    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).
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Other Pre-specified Outcome Measures:
    Title
    Activation and avoidance behaviors
    Description
    Change in mean scores between intervention and control groups in the The Behavioral Activation for Depression Scale-Short Form (BADS-SF) scale.
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Reinforcement probability and environmental suppression
    Description
    Change in mean scores between intervention and control groups in the Reward Probability Index (RPI) scale.
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
    Title
    Response to treatment
    Description
    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.
    Time Frame
    Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daniel Fatori, PhD
    Phone
    +55 11 96162-6183
    Email
    daniel.fatori@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adriana Argeu, Psychologist
    Phone
    +55 11 98603-9059
    Email
    adrianaargeu@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guilherme V Polanczyk, MD, PhD
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    The Effects of Motherly on Postpartum Depression

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