NCT04495166

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

Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).

Conditions

• Perinatal Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2020-11-23
• Completion: 2021-04-27
• First posted: 2020-07-31
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

1 site across 1 country: Brazil