Study data published in JAMA support the efficacy of a digital intervention for depressive symptoms among patients with hypertension or diabetes. In randomized clinical trials (RCTs) conducted in Brazil and Peru, patients displayed significant improvements in depression symptoms following digital treatment. However, results were not sustained at 6 months.
Depression is a known risk factor for cardiovascular disease, particularly among patients with comorbid hypertension and/or diabetes mellitus. To assess whether a digital intervention could reduce depressive symptoms in patients with other cardiovascular risk factors, investigators developed CONEMO, a low-intensity, behavioral activation program accessible through a smartphone.
CONEMO was tested in 2 RCTs: (1) a cluster RCT conducted at 20 sites in São Paulo, Brazil, between 2016 and 2018; and (2) an individual-level RCT conducted at 7 sites in Lima, Peru, between 2017 and 2018. Both trials enrolled adults (21 years of age and older) who received treatment for hypertension and/or diabetes at public health care centers. The Patient Health Questionnaire-9 (PHQ-9) was used to screen for depressive symptoms at baseline; patients with clinically significant depression (PHQ-9 ≥10) were randomly assigned to receive either usual care or CONEMO for 6 weeks. CONEMO was delivered over 18 separate sessions, each requiring fewer than 10 minutes to complete.
The primary outcome was improvement of depression symptoms at 3 months, defined as a reduction of at least 50% from baseline PHQ-9 score. The PHQ-9 was readministered at 6 months to capture sustained treatment response.
Logistic regression models were used to estimate the impact of study conditions on the likelihood of depression improvement. Models were adjusted for baseline PHQ-9 scores, age, sex, education, income, marital status, and medical comorbidities.
A total of 880 and 432 patients were enrolled in the Brazil and Lima RCTs, respectively, among whom 440 and 215 were assigned to the CONEMO condition. In both trials, demographic and clinical characteristics were comparable between study arms.
At month 3, substantial improvements in PHQ-9 score were observed in both CONEMO groups compared with the care-as-usual groups. In the Brazil cohort, a 50% reduction in baseline PHQ-9 score was achieved by 40.7% of the intervention group and 28.6% of the control group (P =.001).
Similarly, a greater proportion of the CONEMO group experienced substantial decreases in PHQ-9 scores compared with the control group (52.7% vs 34.1%; P <.001). In adjusted regression models, the Brazil CONEMO group was significantly more likely to experience PHQ-9 improvements at 3 months compared with the control group (odds ratio [OR], 1.6; 95% CI, 1.2-2.2). In the Peru CONEMO group, the OR of clinical improvement was even greater, at 2.1 (95% CI, 1.4-3.2). However, at 6 months the proportion of patients with improved depressive symptoms was comparable between intervention and control arms in both cohorts.
Results from this study support the efficacy of a smartphone-based behavioral intervention program for the treatment of depression in patients with hypertension and/or diabetes or both. However, although the intervention was associated with significant improvements at 3 months, results were not significantly different from care as usual at 6 months. Such findings suggest that the utility of CONEMO may be limited to the short term.
Investigators also noted that patients in the care as usual condition were offered psychiatric resources if symptoms intensified, which may have diluted study results. The availability of nurse assistance for patients in the intervention condition may have artificially improved adherence or outcomes or both.
“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,” the investigators wrote. “However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months.”
Disclosure: One author reported a pending patent for CONEMO (the digital intervention used in both studies). One author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Araya R, Rossi Menezes P, Garcia Claro H, et al. Effect of a digital intervention on depressive symptoms in patients with comorbid hypertension or diabetes in Brazil and Peru: Two randomized clinical trials. JAMA. 2021;325(18):1852-1862. doi:10.1001/jama.2021.4348