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
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
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
NCT ID
NCT05055674
First Posted
August 31, 2021
Last Updated
September 14, 2021
Sponsor
University of Sao Paulo
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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