title: Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The integrated treatment of first episode psychosis has been shown to improve functionality and negative symptoms in previous studies. In this paper, we describe a study of integrated treatment (individual psychoeducation complementary to pharmacotherapy) versus treatment as usual, comparing results at baseline with those at 6-month re-assessment (at the end of the study) for these patients, and online training of professionals to provide this complementary treatment, with the following objectives: 1) to compare the efficacy of individual psychoeducation as add-on treatment versus treatment as usual in improving psychotic and mood symptoms; 2) to compare adherence to medication, functioning, insight, social response, quality of life, and brain-derived neurotrophic factor, between both groups; and 3) to analyse the efficacy of online training of psychotherapists.
  
  
  METHODS
  This is a single-blind randomised clinical trial including patients with first episode psychosis from hospitals across Spain, randomly assigned to either a control group with pharmacotherapy and regular sessions with their psychiatrist (treatment as usual) or an intervention group with integrated care including treatment as usual plus a psychoeducational intervention (14 sessions). Training for professionals involved at each participating centre was provided by the coordinating centre (University Hospital of Álava) through video conferences. Patients are evaluated with an extensive battery of tests assessing clinical and sociodemographic characteristics (Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Liebowitz Social Anxiety Scale, Hamilton Rating Scale for Depression, Scale to Assess Unawareness of Mental Disorders, Strauss and Carpenter Prognostic Scale, Global Assessment of Functioning Scale, Morisky Green Adherence Scale, Functioning Assessment Short Test, World Health Organization Quality of Life instrument WHOQOL-BREF (an abbreviated version of the WHOQOL-100), and EuroQoL questionnaire), and brain-derived neurotrophic factor levels are measured in peripheral blood at baseline and at 6 months. The statistical analysis, including bivariate analysis, linear and logistic regression models, will be performed using SPSS.
  
  
  CONCLUSIONS
  This is an innovative study that includes the assessment of an integrated intervention for patients with first episode psychosis provided by professionals who are trained online, potentially making it possible to offer the intervention to more patients.
  
  
  BACKGROUND
  NCT01783457 clinical trials.gov. Date of registration in primary registry 23 January 2013.
authors.forename: Sara
authors.initials: S
authors.lastname: Barbeito
authors.forename: Patricia
authors.initials: P
authors.lastname: Vega
authors.forename: Sonia
authors.initials: S
authors.lastname: Ruiz de Azua
authors.forename: Vicent
authors.initials: V
authors.lastname: Balanza-Martinez
authors.forename: Francesc
authors.initials: F
authors.lastname: Colom
authors.forename: Esther
authors.initials: E
authors.lastname: Lorente
authors.forename: Ana
authors.initials: A
authors.lastname: Luengo
authors.forename: Ester
authors.initials: E
authors.lastname: Cerrillo
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Crespo
authors.affiliation: Biomedical Research Centre in Mental Health Net (CIBERSAM), University Hospital of Álava (Santiago Apóstol), Osakidetza, Olaguibel Street, Vitoria, Spain. anamaria.gonzalez-pintoarrillaga@osakidetza.net.
authors.forename: Ana
authors.initials: A
authors.lastname: González Pinto
mesh_terms: D000339:Affect; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D019208:Brain-Derived Neurotrophic Factor / Q000097:blood; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003194:Computer-Assisted Instruction; D006801:Humans; D020407:Internet; D016014:Linear Models; D016015:Logistic Models; D055118:Medication Adherence; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000193:education*; D011618:Psychotic Disorders / Q000097:blood / Q000175:diagnosis / Q000378:metabolism / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D012919:Social Behavior; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D015415:Biomarkers; D019208:Brain-Derived Neurotrophic Factor; C579455:BDNF protein, human