title: Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials NCT01611818.
authors: Departamento de Psicología y Sociología, Universidad de Zaragoza, Zaragoza, Spain.
authors: Yolanda
authors: Y
authors: López-del-Hoyo
authors: Barbara
authors: B
authors: Olivan
authors: Juan V
authors: JV
authors: Luciano
authors: Fermín
authors: F
authors: Mayoral
authors: Miquel
authors: M
authors: Roca
authors: Margalida
authors: M
authors: Gili
authors: Eva
authors: E
authors: Andres
authors: Antoni
authors: A
authors: Serrano-Blanco
authors: Francisco
authors: F
authors: Collazo
authors: Ricardo
authors: R
authors: Araya
authors: Rosa
authors: R
authors: Baños
authors: Cristina
authors: C
authors: Botella
authors: Rosa
authors: R
authors: Magallón
authors: Javier
authors: J
authors: García-Campayo
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000191:economics / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet / Q000191:economics; D008297:Male; D008875:Middle Aged; D012107:Research Design; D013813:Therapy, Computer-Assisted / Q000379:methods*; D016896:Treatment Outcome