Study on the implementation of an interactive technological intervention to improve mental health symptoms in Primary Health Care users (CONEMO Project)

• Grant number: 25/06212-7
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: June 01, 2025
• End date: May 31, 2028
• Field of knowledge: Health Sciences - Collective Health - Preventive Medicine
• Principal Investigator: Paulo Rossi Menezes
• Grantee: Alice Castro Menezes Xavier
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated research grant: 21/12901-9 - National Center for Research and Innovation in Mental Health (CISM), AP.ESP

Abstract

Rationale: Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) are highly prevalent and significantly impact public health, especially in low- and middle-income countries such as Brazil. Studies indicate that between 51.9% and 64.3% of patients in primary care settings present with some form of mental disorder. Despite the proven efficacy of non-pharmacological therapies, access to treatment remains limited due to socioeconomic barriers and the concentration of specialized resources in urban centers. Digital interventions can help overcome these barriers; however, many of these interventions-especially those with minimal professional support-lack robust evidence regarding their effectiveness.Objective: To implement and evaluate the digital intervention called CONEMO (Emotional Control), based on Cognitive Behavioral Therapy (CBT) techniques and delivered with minimal professional support. The main goal is to reduce depressive and anxiety symptoms in adults receiving care through primary health services. The effectiveness of CONEMO for depressive symptoms has already been demonstrated in previous studies.Methodology: The study will be conducted in 24 Basic Health Units (UBS) located in the municipalities of Indaiatuba and Jaguariúna, São Paulo. It is a pragmatic, prospective implementation study. Participants will be recruited via QR codes available at the UBS facilities, leading to a screening questionnaire with personal information and mental health symptoms. Inclusion criteria: aged 18 or older; receiving care at one of the participating UBS; presenting significant symptoms of depression (PHQ-9 ¿ 10) and/or anxiety (GAD-7 ¿ 10); and being able to read the app's instructions on a smartphone or tablet. **Exclusion criteria:** high-risk individuals according to the S-RAP (Suicide Risk Assessment Protocol); these individuals will be referred for emergency care in accordance with the project's Risk Assessment and Monitoring protocol. Eligible participants will access the CONEMO app, and healthcare teams will have access to a secure online platform to monitor patient progress. UBS units will be randomly assigned: half will be able to apply CONEMO for both depression and anxiety simultaneously, while the other half will apply it for depression only. This design aims to evaluate the impact of overlapping interventions on adherence and treatment effectiveness. Effectiveness will be assessed using symptom scales for depression (PHQ-9), anxiety (GAD-7), and insomnia (Insomnia Severity Index - ISI), applied at the end of the intervention and three months later. Implementation outcomes will include qualitative data (acceptability, usability, user experience, engagement) and quantitative data (effectiveness, retention, safety). Healthcare professional involvement will also be assessed through the number of interactions with the CONEMO platform and participation in focus groups. (AU)