IMPORTANCEDepression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low-and middle-income countries, but the effectiveness in these countries is unknown.OBJECTIVE To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension. DESIGN, SETTING, AND PARTICIPANTSParticipants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score Ն10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in

Background Task-shifting and technology in psychological interventions are two solutions to increasing access to mental health intervention and overcoming the treatment gap in low and middle-income countries. The CONEMO intervention combines a smartphone app with support from non-specialized professionals, aiming to treat depression in patients with diabetes and/or hypertension. The aim of this paper is to describe the process of recruitment, training and supervision of the non-specialized professionals who participated in the CONEMO task-shifting intervention in Brazil and Peru. Methods We described and analyzed data related to the recruitment, training and supervision of 62 nurse assistants from the health system in Sao Paulo, Brazil, and three hired nurses in Lima, Peru. The data were collected from information provided by nurses and nurse assistants, supervisor records from supervision meetings and the CONEMO platform database. Results We found that task-shifting was feasible using existing resources in Sao Paulo and additional human resources in Lima. Training and supervision were found to be crucial and well received by the staff; however, time was a limitation when using existing human resources. Ensuring technological competence prior to the start of the intervention was essential. Group supervision meetings allowed non-specialized professionals to learn from each other’s experiences. Conclusion Carefully considering recruitment, training and supervision of non-specialized professionals is important for effective task-shifting when delivering an mHealth intervention for depression. Opportunities and challenges of working in different health systems are described, which should be considered in future implementation, either for research or real settings. Trial registration NCT028406662 (Sao Paulo), NCT03026426 (Peru).

Background: Task-shifting and technology in psychological interventions are two solutions to increasing access to mental health intervention and overcoming the treatment gap in low and middle-income countries. The CONEMO intervention combines a smartphone app with support from non-specialized professionals, aiming to treat depression in patients with diabetes and/or hypertension. The aim of this paper is to describe the process of recruitment, training and supervision of the non-specialized professionals who participated in the CONEMO task-shifting intervention in Brazil and Peru. Methods: We described and analyzed data related to the recruitment, training and supervision of 62 Nurse Assistants from the health system in Sao Paulo, Brazil and three hired Nurses in Lima, Peru. The data was collected from information provided by Nurses and Nurse Assistants, supervisor records from supervision meetings and the CONEMO platform database. Results: We found that task-shifting was feasible using existing resources in Sao Paulo and additional human resources in Lima. Training and supervision were found to be crucial and well received by the staff; however, time was a limitation when using existing human resources. Ensuring technological competence prior to the start of the intervention was essential. Group supervision meetings allowed non-specialized professionals to learn from each other’s experiences. Conclusion: Carefully considering recruitment, training and supervision of non-specialized professionals is important for effective task-shifting when delivering an mHealth intervention for depression. Opportunities and challenges of working in different health systems are described, which should be considered in future implementation, either for research or real settings

BACKGROUND Mobile health (mHealth) interventions provide significant strategies for improving access to health services [1], offering one potential solution to reduce the mental health treatment gap. Economic evaluation can contribute with evidence to the local policy of and program development in mental health. OBJECTIVE This paper presents the protocol for an economic evaluation conducted alongside two randomized controlled trials (RCTs) to evaluate the effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes and/or hypertension. METHODS The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO compared to usual enhanced care from society and public health system perspectives. We recruited participants from the public health systems in Sao Paulo, Brazil (n=880), and Lima, Peru (n=432), and randomized to intervention or enhanced usual care groups RCTs. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost to decrease depressive symptoms by 50% or more. The cost per quality-adjusted life-year (QALY) gained. For effectiveness, our primary outcome is the proportion of participants with a 50% reduction in the Patient Health Questionnaire (PHQ- 9) score at 3-month - calculated through logistic regression. For utility, our primary outcome is the QALYs gained, measured by the EQ-5D-3L. We assessed each dimension at months 3 and 6. Costs will include both direct and indirect costs. The method of measurement will be mixed methods, with a combination of the Top-down and Bottom-up approaches. We will collect unit costs from the RCTs and national administrative databases. We will also calculate incremental cost-effectiveness ratios (ICERs) and display 95% confidence intervals (CI) from non-parametric bootstrapping (1000 replicates). We will calculate the incremental cost-effectiveness rate, as well as a deterministic and probabilistic sensitivity analysis. Finally, we will draw a Cost-Effectiveness Acceptability Curve (CEAC) to compare a range of possible cost-effectiveness limits. RESULTS The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021. CONCLUSIONS We expect to assess if CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared to usual enhanced care. This study will assist health managers in allocating additional resources for mental health initiatives and will inform policymakers. It also provides a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low-income settings. CLINICALTRIAL ClinicalTrials.gov - Brazil NCT02846662 and Peru NCT03026426

Background: Task-shifting and eHealth have been proposed as ways of approaching the mental health treatment gap in low and middle-income countries (LMIC). The Latin America Treatment & Innovation Network in Mental Health (LATIN-MH) developed CONEMO (Emotional Control), a behavioral intervention used to treat depressive symptoms in a sample of patients with diabetes and hypertension in Sao Paulo, Brazil. The intervention uses task shifting and is delivered via a smartphone app. The effectiveness of this intervention was tested in two randomized trials in these countries. Aim: This paper aims to present the protocol for a study that will explore perceived barriers and facilitators to implementing this intervention to help future scale-up. Methods: We will conduct qualitative research with users of the CONEMO intervention and health professionals who participated directly and indirectly in the trial in Brazil. We will use semi-structured interviews, and we will adopt the Consolidated Framework for Implementation Research (CFIR) for data analysis. Discussion: Task-shifting and eHealth are potentially important tools to help decrease the mental health treatment gap in Latin America. This study will increase our understanding of the factors which may facilitate or hinder the implementation of mobile behavioral mental health interventions, using task-shifting, within LMICs. Findings could be used in future design and planning to facilitate successful implementation and treatment. Registration in Clinical Trials (www.clinical.trials.gov) NCT028406662