RESUMO
BACKGROUND: Non-pharmacological interventions have proven effective at alleviating depression and anxiety symptoms in older adults. Methodological refinement and testing of these interventions in new contexts are needed on a small scale before their effectiveness and implementation can be evaluated. The purpose of this pilot study is to assess the feasibility of a future large-scale trial comparing an adapted mental health multi-component evidence-based intervention (VIDACTIVA) versus standard care for older adults experiencing depression symptoms in urban, resource-limited settings in Lima, Peru. Furthermore, this study will explore the acceptability, feasibility, and fidelity of implementing the intervention. METHODS: We will conduct an open-label, mixed methods pilot feasibility study with two parallel groups. A total of 64 older adults, stratified by sex, will be randomized at a 1:1 ratio to either the "intervention" or "control." Participants will be followed for 22 weeks after enrollment. Those in the intervention group will receive eight VIDACTIVA sessions administered by community health workers (CHWs) over 14 weeks, with an additional eight weeks of follow-up. Participants in the control group will receive two psychoeducation sessions from a study fieldworker and will be directed to health care centers. Standard care does not involve CHWs. We will evaluate screening rates, recruitment strategies, retention rates, the acceptability of randomization, and assessments. Additionally, we will assess preliminary implementation outcomes-acceptability, feasibility, and fidelity-from the perspectives of CHWs (interventionists), older adults (main participants), older adults' relatives, and healthcare professionals. DISCUSSION: If the findings from this feasibility trial are favorable, a fully powered randomized controlled trial will be conducted to evaluate `both the effectiveness and implementation of the intervention. This research will make a substantial contribution to the field of mental health in older adults, particularly by emphasizing a meticulous examination and documentation of the implementation process. By doing so, this study will offer valuable methodologies and metrics for adapting and assessing mental health interventions tailored to the unique needs of older adults in resource-constrained contexts and diverse cultural settings. TRIAL REGISTRATION: The current trial registration number is NCT06065020, which was registered on 26th September 2023.
RESUMO
RESUMEN Objetivo: Determinar la asociación entre diabetes mellitus y depresión crónica en adultos en la población peruana. Materiales y métodos: Se realizó un estudio cuantitativo, de tipo observacional, de corte transversal y correlacional, a partir de los datos recogidos por la encuesta demográfica y de salud familiar del 2020 (Endes 2020). La muestra estuvo conformada por 14 245 adultos. La variable dependiente fue la depresión (con depresión/sin depresión); las variables independientes fueron diabetes mellitus (sí/no), índice de riqueza (los más pobres, pobre, medio, rico, más rico), educación (inicial-preescolar y primaria, secundaria, superior no universitaria, superior universitaria y posgrado), alcoholismo (sí/no) y área de residencia (urbano/rural). Para el análisis estadístico, se empleó el programa SPSS, versión 23, donde se realizó un análisis univariado de los datos mediante la determinación de las frecuencias y porcentajes. Posteriormente, en la fase analítica, se utilizó el análisis bivariado y multivariado por regresión logística para evaluar la fuerza de asociación entre las variables (p < 0,05). Resultados: El 15,7 % de adultos entre los 27 y 59 años presentaron depresión crónica; además, en el análisis bivariado se encontró asociación de la variable resultado y las covariables diabetes mellitus, nivel de educación e índice de riqueza (p < 0,05). La depresión es más frecuente en grupos socioeconómicos más bajos, con tasas más altas entre la población pobre (16,63 %) y menos educada, especialmente en aquellos con educación inicial-preescolar y primaria (18,88 %). En contraste, las clases ricas y más ricas muestran tasas menores de depresión (15,27 % y 12,04 %, respectivamente). Por otro lado, en el análisis multivariado se realizó la estimación del riesgo y se encontró que ser diabético aumentó el riesgo 1,66 veces más de padecer depresión en relación con los no diabéticos. Conclusiones: Existe asociación entre depresión crónica y diabetes mellitus en la población adulta de 27 a 59 años, además, el bajo índice de riqueza y tener menor grado de educación son factores de riesgo para el trastorno depresivo crónico.
ABSTRACT Objective: To determine the association between diabetes mellitus and chronic depression in adults in the Peruvian population. Materials and methods: A quantitative, observational, cross-sectional and correlational study was carried out, based on the data collected by the 2020 Encuesta Demográfica y de Salud Familiar (ENDES - Demographic and Family Health Survey, 2020). The sample was made up of 14,245 adults; depression was considered as a dependent variable (with depression/without depression), and the independent variables were diabetes mellitus (Yes/No), wealth index (the poorest, poor, middle class, rich, the richest), education (kindergarten-preschool and primary, secondary, non-university higher, university higher and graduate), alcoholism (Yes/No), area of residence (urban/rural). The program used for the statistical analysis was IBM SPSS: Release 23. A univariate data analysis was carried out by determining the frequencies and percentages. Subsequently, in the analytical phase, bivariate and multivariate analyses by logistic regression were used to evaluate the strength of the association between the variables (p < 0.05). Results: A total of 15.7 % of adults between 27 and 59 years of age experienced chronic depression. Furthermore, the bivariate analysis revealed an association between the outcome variable and covariates-diabetes mellitus, level of education and wealth index-(p < 0.05). Depression is more common in lower socioeconomic groups, with higher rates among the poor (16.63 %) and less educated population, especially in those with kindergarten, preschool and primary education (18.88 %). In contrast, the rich and richest classes show lower rates of depression (15.27 % and 12.04 %, respectively). On the other hand, in the multivariate analysis, the risk estimation was carried out, and it was found that having diabetes increased the risk of suffering depression by 1.66 times compared to patients who did not have diabetes. Conclusions: There is an association between chronic depression and diabetes mellitus in the adult population aged 27 to 59 years; in addition, a low wealth index and a lower level of education are risk factors for chronic depressive disorder.