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Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials

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dc.contributor.author Araya, Ricardo
dc.contributor.author Rossi-Menezes, Paulo
dc.contributor.author García-Claro, Heloísa
dc.contributor.author Brandt, Lena R.
dc.contributor.author Daley, Kate L.
dc.contributor.author Quayle, Julieta
dc.contributor.author Diez-Canseco Montero, Francisco
dc.contributor.author Peters, Tim J.
dc.contributor.author Vera-Cruz, Daniela
dc.contributor.author Toyama, Mauricio
dc.contributor.author Aschar, Suzana
dc.contributor.author Hidalgo Padilla, Liliana Milagros
dc.contributor.author Martins, Hellen
dc.contributor.author Cavero, Victoria
dc.contributor.author Rocha, Thais
dc.contributor.author Scotton, George
dc.contributor.author de Almeida Lopes, Ivan F.
dc.contributor.author Begale, Mark
dc.contributor.author Mohr, David C.
dc.contributor.author Miranda, J. Jaime
dc.date.accessioned 2021-06-08T15:46:13Z
dc.date.available 2021-06-08T15:46:13Z
dc.date.issued 2021
dc.identifier.uri https://hdl.handle.net/20.500.12866/9485
dc.description.abstract 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 en_US
dc.language.iso eng
dc.publisher American Medical Association
dc.relation.ispartofseries JAMA
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Female en_US
dc.subject Humans en_US
dc.subject Male en_US
dc.subject Middle Aged en_US
dc.subject Peru en_US
dc.subject Adult en_US
dc.subject Brazil en_US
dc.subject *Mobile Applications en_US
dc.subject *Telemedicine en_US
dc.subject Behavior Therapy/*methods en_US
dc.subject Depression/complications/nursing/*therapy en_US
dc.subject Diabetes Mellitus/*psychology en_US
dc.subject Hypertension/*psychology en_US
dc.subject Odds Ratio en_US
dc.subject Smartphone en_US
dc.title Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1001/jama.2021.4348
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00
dc.relation.issn 1538-3598


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