Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVE: Depression is a prevalent mental health condition with a significant global burden, yet treatment coverage remains limited. Digital interventions offer a promising avenue for expanding access to evidence-based interventions. METHODS: In a three-arm randomized clinical trial, we evaluated the efficacy and safety of an app-based intervention and an online group cognitive behavioral therapy (GCBT) to reduce depressive symptoms compared to a waiting list control (WLC). Participants (N = 109) with PHQ-9 scores ≥ 9 were randomized into three groups. Informed consent was obtained. The primary outcome, depressive symptoms, was assessed at baseline and every 4 weeks over 12 weeks. Secondary outcomes included anxiety symptoms, loneliness perception, and treatment-related adverse effects. We used one-tailed Student's t-tests and Mann-Whitney U tests, adjusting p-values for false discovery rate. Statistical significance was set at 5%. ClinicalTrials.gov identifier: NCT05450614. RESULTS: After excluding dropouts, 58 participants remained (28 app; 19 GCBT; 11 WLC). Most were women (app: 86%; GCBT: 89%; WLC: 100%) and identified as white (app: 61%; GCBT: 63%; WLC: 82%), aged 36 to 39, with high income and education. Only GCBT showed a significant reduction in anxiety (t(23.92) = 2.20, p = 0.019; padj = 0.038; Cohen's d = 0.81, 95%CI [0.17, ∞). The remaining comparisons were not statistically significant. CONCLUSION: While only GCBT showed significant improvement in anxiety symptoms, both treatments showed trends toward depressive symptom reduction. High dropout rates and a small sample may have impacted results. Further research should assess the long-term impact and scalability of digital interventions in mental health.
Authors: Júlio César Bebber, Bruno Braga Montezano, Analise de Souza Vivan, Thyago Antonelli-Salgado, Kyara Rodrigues de Aguiar, Aline Zimerman, Augusto Ossamu Shintani, Marta Braga Ryff Moreira, Roberta Campos, Lidiane Rodrigues, Guilenne Frisina Zaffari, Glória Mallmann, Rafaela Fernandes Pulice, Victória Chiodelli Senger, Juliana Rosendo Vargas, Camila Zimmer, Mirian Cristina dos Santos Amaral, Gabriel Gonçalves Veloso, Giancarlo Franceschi Dalla Vecchia, Júlio César Bisognin Lopez, André Russowsky Brunoni, Francisco Diego Rabelo-da-Ponte, Ives Cavalcante Passos, Daniela Tusi Braga
Language: English
Subfield: Applied Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: diamond
OpenAlex ID: W4410219105