JMIR Publications

ABSTRACT

Background:

Mobile health (mHealth) interventions provide significant strategies for improving access to health services, offering one potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development.

Objective:

This paper presents the protocol for an economic evaluation conducted alongside two randomized controlled trials (RCTs) to evaluate the cost-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 plus enhanced usual care compared to enhanced usual care from public healthcare system and societal perspectives. RCT participants are patients of the public healthcare services for hypertension and/or diabetes in São Paulo, Brazil (n=880), and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50% reduction on PHQ-9 scores, and cost per quality-adjusted life-year (QALY) gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (i.e., a combination of top-down and bottom-up approaches) considering four cost categories: intervention (CONEMO-related) costs, healthcare costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios (ICERs) and display 95% confidence intervals (CI) from non-parametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analysis. Finally, we will present cost-effectiveness acceptability curves (CEAC) to compare a range of possible cost-effectiveness thresholds.

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 enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries. Clinical Trial: ClinicalTrials.gov - Brazil NCT02846662 and Peru NCT03026426