Depression Clinical Trial
Official title:
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
BACKGROUND: Major depression will become the second most important cause of disability in
2020. Computerised 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 have been carried out.
AIM: 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 computerised
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.
n/a
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