The Effects of Motherly on Postpartum Depression

September 14, 2021 updated by: Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo

Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: Motherly app
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.
ACTIVE_COMPARATOR: COMVC App
Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring.
Behavioral: COMVC app
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression symptoms
Time Frame: 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)
Posttreatment (T1) 1 month after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression symptoms
Time Frame: Follow-up (T2) 2 months after baseline
Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS)
Follow-up (T2) 2 months after baseline
Anxiety symptoms
Time Frame: 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)
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Sleep quality
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Physical Health
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Quality of Life: Mental Health
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting stress
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parental Distress
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parent-child Dysfunctional Interaction
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Difficult Child
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Attachment
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Parenting Competence
Time Frame: 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).
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activation and avoidance behaviors
Time Frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Change in mean scores between intervention and control groups in the The Behavioral Activation for Depression Scale-Short Form (BADS-SF) scale.
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Reinforcement probability and environmental suppression
Time Frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Change in mean scores between intervention and control groups in the Reward Probability Index (RPI) scale.
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Response to treatment
Time Frame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
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.
Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guilherme V Polanczyk, MD, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OR2019-62903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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