A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

NACompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

August 3, 2020

Primary Completion Date

November 23, 2020

Study Completion Date

April 27, 2021

Conditions
Perinatal Depression
Interventions
BEHAVIORAL

Motherly 1.0

A mobile app designed to promote life habits that have been shown to improve physical and mental health in pregnant women. The app consists of a package of specific and customized interventions defined by eight different modules: 1) Mental Health; 2) Sleep; 3) Nutrition; 4) Physical activity; 5) Social support; 6) Prenatal support; 7) Postnatal support, and 8) Library of pre and postnatal content. The app relies on extensive psychoeducational content delivered as tutorials, brief messages, and available as a library that can be read at the users' discretion; behavior monitoring using schedules, checklists, and notifications to help participants keep track of their health care visits, and schedule behavior activation activities; and gaming elements such as changes in background appearance to reflect participant's mood assessment and ratings of activities, and graphical and easy-to-use questionnaires for obtaining information (mood, nutrition habits).

BEHAVIORAL

Brief Psychotherapy

Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.

BEHAVIORAL

Educational app

A simplified version of the Motherly 1.0 app consisting of psychoeducational content about various aspects of pregnancy, maternal physical and mental health, and child development. Active intervention functionalities, such as behavioral activation, activity scheduling, sleep hygiene, among others, are NOT present in this simplified version of the app.

Trial Locations (1)

Unknown

Daniel Fatori, São Paulo

All Listed Sponsors
collaborator

Grand Challenges Canada

OTHER

collaborator

Fundação Maria Cecilia Souto Vidigal

OTHER

lead

University of Sao Paulo

OTHER

NCT04495166 - A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression | Biotech Hunter | Biotech Hunter