What is the effect of a behavioral activation digital intervention delivered over a 6-week period on depressive symptoms among patients with comorbid hypertension or diabetes in Brazil and Peru?
In 2 randomized clinical trials conducted separately in São Paulo, Brazil (880 participants), and Lima, Peru (432 participants), a significantly greater proportion of participants who received the digital intervention, compared with enhanced usual care, experienced at least a 50% reduction in depressive symptoms at 3 months (40.7% vs 28.6% in Brazil; [odds ratio, 1.6]; 52.7% vs 34.1% in Peru [odds ratio, 2.1]), although the differences were no longer statistically significant at 6 months.
A digital intervention for patients with depressive symptoms and comorbid hypertension or diabetes significantly improved depressive symptoms at 3 months compared with enhanced usual care in Peru and Brazil, but the effects were not sustained at 6 months in either of the 2 trials.
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.
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).
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.
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.
ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima)
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Authors: Ricardo Araya, MD, PhD, Centre for Global Mental Health, King’s College London, Five De Crespigny Park, London SE5 8AF, United Kingdom (email@example.com); Jaime Miranda, MD, PhD, Centro de Excelencia en Enfermedades Crónicas, Universidad Peruana Cayetano Heredia, Av Armendáriz 445, Miraflores, Lima 18, Perú (firstname.lastname@example.org).
Accepted for Publication: March 8, 2021.
Author Contributions: Dr Araya had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Joint first authors: Drs Araya and Menezes. Joint senior authors: Drs Mohr and Miranda.
Concept and design: Araya, Menezes, Garcia Claro, Diez-Canseco, Peters, Martins Castro, Begale, Mohr, Miranda.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Araya, Menezes, Garcia Claro, Daley, Quayle, Diez-Canseco, Santos, Rocha, Scotton, Fernandes, Begale, Mohr, Miranda.
Critical revision of the manuscript for important intellectual content: Araya, Menezes, Garcia Claro, Brandt, Diez-Canseco, Peters, Toyama, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Fernandes, Mohr, Miranda.
Statistical analysis: Araya, Menezes, Garcia Claro, Peters, Scotton, Fernandes.
Obtained funding: Araya, Menezes, Mohr, Miranda.
Administrative, technical, or material support: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Santos, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Rocha, Scotton, Begale, Mohr, Miranda.
Supervision: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Cavero, Miranda.
Other - quantitative aspects of the trial design: Peters.
Conflict of Interest Disclosures: Dr Araya reported a pending patent for CONEMO (the digital intervention used in both studies). Dr Menezes reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Brandt reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Diez-Canseco reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Hidalgo-Padilla reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Cavero reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Rocha reported receipt of grants from NIMH during the conduct of the study. Dr Scotton reported receipt of grants from NIMH during the conduct of the study. Dr Mohr reported receipt of grants from NIMH during the conduct of the study; personal fees from Otsuka Pharmaceuticals, from Apple Inc, Pear Therapeutics, and One Mind Foundation; and other from Adaptive Health Inc Equity Interest outside the submitted work. Dr Miranda reported receipt of grants from NIMH during the conduct of the study. No other disclosures were reported.
Funding/Support: This project was funded by NIMH (U19MH098780).
Role of the Funder/Sponsor: NIMH researchers composed the data and safety monitoring board (DSMB) and executive committee and took part in reviewing and approving research protocols and DSMB reports. The funder did not take part in the data collection or analysis. Funders did not participate in the preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank all of the staff, especially the nurses, and the study participants.
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