Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial

• Published in: BMC psychiatry Vol. 15; no. 1; p. 106
• Main Authors: Castro, Adoración, García-Palacios, Azucena, García-Campayo, Javier, Mayoral, Fermín, Botella, Cristina, García-Herrera, José María, Pérez-Yus, Mari-Cruz, Vives, Margalida, Baños, Rosa M, Roca, Miquel, Gili, Margalida
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 07.05.2015; BioMed Central
• Subjects: Adult; Analysis; Care and treatment; Clinical Protocols; Depression - psychology; Depression - therapy; Depression, Mental; Female; Health aspects; Health Promotion - methods; Humans; Male; Medical research; Medicine, Experimental; Mindfulness - methods; Mindfulness meditation; Patient outcomes; Primary Health Care - methods; Psychotherapy; Psychotherapy - methods; Study Protocol; Therapy, Computer-Assisted; Young Adult
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-015-0475-0

Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs. Low-intensity psychological interventions applied by Information and Communication Technologies (ICTs) could be an efficacious and cost-effective therapeutic option for the treatment of depression. The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs (healthy lifestyle, positive affect and mindfulness) in Primary Care; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions, but ICTs were not used. Multicenter controlled randomized clinical trial in 4 parallel groups. Interventions have been designed and on-line device adaptation has been carried out. Subsequently, the randomized controlled clinical trial will be conducted. A sample of N = 240 mild and moderate depressed patients will be recruited and assessed in Primary Care settings. Patients will be randomly assigned to a) healthy lifestyle psychoeducational program + improved primary care usual treatment (ITAU), b) focused program on positive affect promotion + ITAU c) mindfulness + ITAU or d) ITAU. The intervention format will be one face to face session and four ICTs on-line modules. Patients will be diagnosed with MINI psychiatric interview. Main outcome will be PHQ-9 score. They will be also assessed by SF-12 Health Survey, Client Service Receipt Inventory, EuroQoL-5D questionnaire, Positive and Negative Affect Scale, Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index. Patients will be assessed at baseline, post, 6 and 12 post-treatment months. An intention to treat and per protocol analysis will be performed. Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment. The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs (healthy lifestyle psychoeducational program; focused program on positive affect promotion and brief intervention based on mindfulness) in Primary Care settings. Current Controlled Trials ISRCTN82388279 . Registered 16 April 2014.