title: Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.
abstract: Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used.
  
  
  
  This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment.
  
  
  
  This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients.
  
  
  
  NCT02924415 . Retrospectively registered 27 September 2016.
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain. itxaso.gonzalezortega@osakidetza.eus.
authors.forename: Itxaso
authors.initials: I
authors.lastname: González-Ortega
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
authors.forename: Amaia
authors.initials: A
authors.lastname: Ugarte
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
authors.forename: Sonia
authors.initials: S
authors.lastname: Ruiz de Azúa
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Núñez
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Zubia
authors.affiliation: Centro de Investigación en Cronicidad-Kronikgune, Barakaldo, Spain.
authors.forename: Sara
authors.initials: S
authors.lastname: Ponce
authors.affiliation: IK4-Tekniker, Gipuzkoa, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Casla
authors.affiliation: Osatek, Bilbo, Spain.
authors.forename: Josu Xabier
authors.initials: JX
authors.lastname: Llano
authors.affiliation: Subdirección de Informática, Sistemas de Información-Osakidetza, Vitoria, Spain.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Faria
authors.affiliation: Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: González-Pinto
mesh_terms: D001714:Bipolar Disorder / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D005060:Europe; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D011788:Quality of Life / Q000523:psychology; D012107:Research Design; D012648:Self Care / Q000379:methods; D016037:Single-Blind Method; D017216:Telemedicine / Q000379:methods*; D016896:Treatment Outcome
keywords: Bipolar disorder; Psychoeducation; Telemedicine