Study protocol
Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study
1 Departamento de Psicología y Sociología, Universidad de Zaragoza, Zaragoza, Spain
2 Parc Sanitari Sant Joan de Déu and Fundación Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain
3 Psychiatric Service, University Hospital Carlos Haya, Malaga, Spain
4 Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain
5 Unidad Epidemiología Clínica, Hospital 12 de Octubre, CIBER Epidemiología y Salud Pública, Madrid, Spain
6 Servei de Psiquiatria, Hospital Universitari Vall d'Hebron, Barcelona, Spain
7 Academic Unit of Psychiatry, School of Social and Community Medicine, University of Bristol, Bristol, UK
8 Universidad de Valencia, Madrid, Spain
9 Universitat Jaume I, Castellon, Spain
10 Ciber Fisiopatología de la Obesidad y Nutrición (CB06/03), Instituto de Salud Carlos III, Madrid, Spain
BMC Psychiatry 2013, 13:21 doi:10.1186/1471-244X-13-21
Published: 11 January 2013Abstract
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.
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
