RESUMO
BACKGROUND: Mobile health interventions provide significant strategies for improving access to health services, offering a 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 2 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, hypertension, or both. METHODS: The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions 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 in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year 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 (ie, a combination of top-down and bottom-up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care 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 and present 95% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves 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 whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26164.
RESUMO
Importance: Depression 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 Participants: Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018). Interventions: An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima). Main Outcomes and Measures: The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months. Results: Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant. Conclusions and Relevance: In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months. Trial Registration: ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).
