RT Journal Article T1 Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study. A1 López-del-Hoyo, Yolanda A1 Olivan, Barbara A1 Luciano, Juan V A1 Mayoral, Fermín A1 Roca, Miquel A1 Gili, Margalida A1 Andres, Eva A1 Serrano-Blanco, Antoni A1 Collazo, Francisco A1 Araya, Ricardo A1 Baños, Rosa A1 Botella, Cristina A1 Magallón, Rosa A1 García-Campayo, Javier K1 Depression K1 Computer-delivered psychotherapy K1 Randomized controlled trial K1 Trastorno depresivo mayor K1 Diseño de la investigación K1 Tratamiento asistido por ordenador K1 Resultado del tratamiento K1 Protocolos clínicos K1 Terapia cognitiva K1 Análisis Costo-Beneficio AB BACKGROUNDMajor depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.METHODSThe study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.DISCUSSIONThe comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting.TRIAL REGISTRATIONClinical Trials NCT01611818. PB BioMed Central YR 2013 FD 2013-01-11 LK http://hdl.handle.net/10668/1394 UL http://hdl.handle.net/10668/1394 LA en NO López-del-Hoyo Y, Olivan B, Luciano JV, Mayoral F, Roca M, Gili M, et al. Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study. BMC Psychiatry. 2013; 13:21 NO Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Trial registration: Clinical Trials NCT01611818 DS RISalud RD Apr 6, 2025