title: Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN82388279 . Registered 16 April 2014.
authors.affiliation: Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain. a.castro@uib.es.|Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. a.castro@uib.es.
authors.forename: Adoración
authors.initials: A
authors.lastname: Castro
authors.affiliation: Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, University Jaume I, Castellon, Spain. azucena@uji.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERobn), Instituto Salud Carlos III, Madrid, Spain. azucena@uji.es.
authors.forename: Azucena
authors.initials: A
authors.lastname: García-Palacios
authors.affiliation: Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. jgarcamp@gmail.com.|Department of Psychiatry. Hospital Miguel Servet, University of Zaragoza, Zaragoza, Spain. jgarcamp@gmail.com.
authors.forename: Javier
authors.initials: J
authors.lastname: García-Campayo
authors.affiliation: Mental Health Department, University Regional Hospital of Málaga, Institute of Biomedicine of Málaga, Málaga, Spain. fermin.mayoral.sspa@juntadeandalucia.es.
authors.forename: Fermín
authors.initials: F
authors.lastname: Mayoral
authors.affiliation: Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, University Jaume I, Castellon, Spain. botella@uji.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERobn), Instituto Salud Carlos III, Madrid, Spain. botella@uji.es.
authors.forename: Cristina
authors.initials: C
authors.lastname: Botella
authors.affiliation: Mental Health Department, University Regional Hospital of Málaga, Institute of Biomedicine of Málaga, Málaga, Spain. josemgherrera@gmail.com.
authors.forename: José María
authors.initials: JM
authors.lastname: García-Herrera
authors.affiliation: Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. mcperezy.iacs@aragon.es.
authors.forename: Mari-Cruz
authors.initials: MC
authors.lastname: Pérez-Yus
authors.affiliation: Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain. m.vives@uib.es.|Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. m.vives@uib.es.
authors.forename: Margalida
authors.initials: M
authors.lastname: Vives
authors.affiliation: Department of Psychological, Personality, Evaluation and Treatment, University of Valencia, Valencia, Spain. banos@uv.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERobn), Instituto Salud Carlos III, Madrid, Spain. banos@uv.es.
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Baños
authors.affiliation: Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain. mroca@uib.es.|Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. mroca@uib.es.
authors.forename: Miquel
authors.initials: M
authors.lastname: Roca
authors.affiliation: Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain. mgili@uib.es.|Red de Investigación en Actividades Preventivas y Promoción de la Salud, Instituto de Salud Carlos III, Madrid, Spain. mgili@uib.es.
authors.forename: Margalida
authors.initials: M
authors.lastname: Gili
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003863:Depression / Q000523:psychology / Q000628:therapy*; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D064866:Mindfulness / Q000379:methods*; D011320:Primary Health Care / Q000379:methods*; D011613:Psychotherapy / Q000379:methods*; D013813:Therapy, Computer-Assisted; D055815:Young Adult