RT Journal Article T1 A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial A1 Carrasco-Hernández, Laura A1 Jódar-Sánchez, Francisco A1 Núñez-Benjumea, Francisco A1 Moreno Conde, Jesús A1 Mesa González, Marco A1 Civit-Balcells, Antón A1 Hors-Fraile, Santiago A1 Parra-Calderón, Carlos L. A1 Bamidis, Panagiotis D. A1 Ortega Ruiz, Francisco K1 Tabaquismo - Tratamiento AB Objective: This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology.Methods: A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. Results: In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, p=0.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, p=0.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (p=0.84). None of the clinical secondary objective measures showed relevant differences between the groups. Conclusions: The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. PB JMIR PUBLICATIONS, INC YR 2020 FD 2020 LK https://hdl.handle.net/10630/33627 UL https://hdl.handle.net/10630/33627 LA eng NO Carrasco-Hernandez, L., Jódar-Sánchez, F., Núñez-Benjumea, F., Moreno Conde, J., Mesa González, M., Civit-Balcells, A., Hors-Fraile, S., Parra-Calderón, C. L., Bamidis, P. D., & Ortega-Ruiz, F. (2020). A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR mHealth and uHealth, 8(4), e17530. https://doi.org/10.2196/17530 NO This research was funded by the H2020 European Commission research and innovation program (grant agreement 681120) aspart of the SmokeFreeBrain project (www.smokefreebrain.eu) DS RIUMA. Repositorio Institucional de la Universidad de Málaga RD 21 ene 2026