López-del-Hoyo, YolandaOlivan, BarbaraLuciano, Juan VMayoral, FermínRoca, MiquelGili, MargalidaAndres, EvaSerrano-Blanco, AntoniCollazo, FranciscoAraya, RicardoBaños, RosaBotella, CristinaMagallón, RosaGarcía-Campayo, Javier2013-11-252013-11-252013-01-11López-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; 13:21http://hdl.handle.net/10668/1394Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Trial registration: Clinical Trials NCT01611818BACKGROUND Major 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. METHODS The 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. DISCUSSION The 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 REGISTRATION Clinical Trials NCT01611818.enDepressionComputer-delivered psychotherapyRandomized controlled trialTrastorno depresivo mayorDiseño de la investigaciónTratamiento asistido por ordenadorResultado del tratamientoProtocolos clínicosTerapia cognitivaAnálisis Costo-BeneficioMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical ProtocolsMedical Subject Headings::Psychiatry and Psychology::Behavioral Disciplines and Activities::Psychotherapy::Behavior Therapy::Cognitive TherapyMedical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit AnalysisMedical Subject Headings::Psychiatry and Psychology::Mental Disorders::Mood Disorders::Depressive Disorder::Depressive Disorder, MajorMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks::InternetMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle AgedMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research DesignMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Therapy, Computer-AssistedMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment OutcomeMedical Subject Headings::Named Groups::Persons::Age Groups::Adultresearch article23312003open access10.1186/1471-244X-13-211471-244XPMC3626601