Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial. 2014

Sara Barbeito, and Patricia Vega, and Sonia Ruiz de Azua, and Vicent Balanza-Martinez, and Francesc Colom, and Esther Lorente, and Ana Luengo, and Ester Cerrillo, and José Manuel Crespo, and Ana González Pinto

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.

UI MeSH Term Description Entries
D011237 Predictive Value of Tests In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test. Negative Predictive Value,Positive Predictive Value,Predictive Value Of Test,Predictive Values Of Tests,Negative Predictive Values,Positive Predictive Values,Predictive Value, Negative,Predictive Value, Positive
D011569 Psychiatric Status Rating Scales Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness. Factor Construct Rating Scales (FCRS),Katz Adjustment Scales,Lorr's Inpatient Multidimensional Psychiatric Rating Scale,Wittenborn Scales,Edinburgh Postnatal Depression Scale,Mini International Neuropsychiatric Interview
D011613 Psychotherapy A generic term for the treatment of mental illness or emotional disturbances primarily by verbal or nonverbal communication. Psychotherapies
D011618 Psychotic Disorders Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994) Psychoses,Psychosis, Brief Reactive,Schizoaffective Disorder,Schizophreniform Disorders,Psychosis,Brief Reactive Psychoses,Brief Reactive Psychosis,Disorder, Psychotic,Disorder, Schizoaffective,Disorder, Schizophreniform,Disorders, Psychotic,Disorders, Schizoaffective,Disorders, Schizophreniform,Psychoses, Brief Reactive,Psychotic Disorder,Reactive Psychoses, Brief,Reactive Psychosis, Brief,Schizoaffective Disorders,Schizophreniform Disorder
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D011795 Surveys and Questionnaires Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions. Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002985 Clinical Protocols Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy. Protocols, Clinical,Research Protocols, Clinical,Treatment Protocols,Clinical Protocol,Clinical Research Protocol,Clinical Research Protocols,Protocol, Clinical,Protocol, Clinical Research,Protocols, Clinical Research,Protocols, Treatment,Research Protocol, Clinical,Treatment Protocol
D003131 Combined Modality Therapy The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used. Multimodal Treatment,Therapy, Combined Modality,Combined Modality Therapies,Modality Therapies, Combined,Modality Therapy, Combined,Multimodal Treatments,Therapies, Combined Modality,Treatment, Multimodal,Treatments, Multimodal
D003194 Computer-Assisted Instruction A self-learning technique, usually online, involving interaction of the student with programmed instructional materials. Programmed Instruction, Computerized,Self-Instruction Programs, Computerized,Computer Assisted Instruction,Computer-Assisted Instructions,Computerized Programmed Instruction,Computerized Self-Instruction Program,Computerized Self-Instruction Programs,Instruction, Computer-Assisted,Instruction, Computerized Programmed,Instructions, Computer-Assisted,Program, Computerized Self-Instruction,Programs, Computerized Self-Instruction,Self Instruction Programs, Computerized,Self-Instruction Program, Computerized

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