title: Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants.
abstract: Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services.
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy; Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy; mirella.ruggeri@univr.it.
authors.forename: Mirella
authors.initials: M
authors.lastname: Ruggeri
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Chiara
authors.initials: C
authors.lastname: Bonetto
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy; Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy;
authors.forename: Antonio
authors.initials: A
authors.lastname: Lasalvia
authors.affiliation: Department of Mental Health, Azienda ULSS Bologna, Bologna, Italy;
authors.forename: Angelo
authors.initials: A
authors.lastname: Fioritti
authors.affiliation: Scientific Direction, St John of God Clinical Research Centre of Brescia, Brescia, Lombardia, Italy;
authors.forename: Giovanni
authors.initials: G
authors.lastname: de Girolamo
authors.affiliation: Department of Neurosciences, University of Padova, Padova, Italy and Azienda Ospedaliera Padova, Italy;
authors.forename: Paolo
authors.initials: P
authors.lastname: Santonastaso
authors.affiliation: Department of Mental Health, Azienda ULSS Bologna, Bologna, Italy;
authors.forename: Francesca
authors.initials: F
authors.lastname: Pileggi
authors.affiliation: Department of Mental Health, Azienda ULSS Modena, Modena, Italy; Agenzia Sanitaria e Sociale Regionale, Regione Emilia Romagna, Italy;
authors.forename: Giovanni
authors.initials: G
authors.lastname: Neri
authors.affiliation: Department of Mental Health, Rimini, Italy;
authors.forename: Daniela
authors.initials: D
authors.lastname: Ghigi
authors.affiliation: Department of Mental Health, Parma, Italy;
authors.forename: Franco
authors.initials: F
authors.lastname: Giubilini
authors.affiliation: Department of Mental Health, Firenze, Italy;
authors.forename: Maurizio
authors.initials: M
authors.lastname: Miceli
authors.affiliation: Department of Psychiatry, University of Milano, Milano, Italy;
authors.forename: Silvio
authors.initials: S
authors.lastname: Scarone
authors.affiliation: AO Ospedale Niguarda Ca' Granda Milano, MHD Programma 2000, Milan, Italy;
authors.forename: Angelo
authors.initials: A
authors.lastname: Cocchi
authors.affiliation: Department of Mental Health, Bolzano, Italy;
authors.forename: Stefano
authors.initials: S
authors.lastname: Torresani
authors.affiliation: Department of Psychiatry, University of Firenze, Firenze, Italy;
authors.forename: Carlo
authors.initials: C
authors.lastname: Faravelli
authors.affiliation: Department of Mental Health, Azienda Ospedaliera Padova, Padova, Italy;
authors.forename: Carla
authors.initials: C
authors.lastname: Cremonese
authors.affiliation: Department of Mental Health, Azienda ULSS 16, Padova, Italy;
authors.forename: Paolo
authors.initials: P
authors.lastname: Scocco
authors.affiliation: Department of Mental Health, Parma, Italy;
authors.forename: Emanuela
authors.initials: E
authors.lastname: Leuci
authors.affiliation: Department of Mental Health, Modena, Italy;
authors.forename: Fausto
authors.initials: F
authors.lastname: Mazzi
authors.affiliation: Department of Mental Health, Rimini, Italy;
authors.forename: Michela
authors.initials: M
authors.lastname: Pratelli
authors.affiliation: Department of Mental Health, Rimini, Italy;
authors.forename: Francesca
authors.initials: F
authors.lastname: Bellini
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy; Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy;
authors.forename: Sarah
authors.initials: S
authors.lastname: Tosato
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy; Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy;
authors.forename: Katia
authors.initials: K
authors.lastname: De Santi
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Sarah
authors.initials: S
authors.lastname: Bissoli
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Sara
authors.initials: S
authors.lastname: Poli
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Elisa
authors.initials: E
authors.lastname: Ira
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Silvia
authors.initials: S
authors.lastname: Zoppei
authors.affiliation: Department of Mental Health, Azienda ULSS Bologna, Bologna, Italy; Agenzia Sanitaria e Sociale Regionale, Regione Emilia Romagna, Italy;
authors.forename: Paola
authors.initials: P
authors.lastname: Rucci
authors.affiliation: AO Ospedale Niguarda Ca' Granda Milano, MHD Programma 2000, Milan, Italy;
authors.forename: Laura
authors.initials: L
authors.lastname: Bislenghi
authors.affiliation: AO Ospedale Niguarda Ca' Granda Milano, MHD Programma 2000, Milan, Italy;
authors.forename: Giovanni
authors.initials: G
authors.lastname: Patelli
authors.affiliation: Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy;
authors.forename: Doriana
authors.initials: D
authors.lastname: Cristofalo
authors.affiliation: AO Ospedale Niguarda Ca' Granda Milano, MHD Programma 2000, Milan, Italy;
authors.forename: Anna
authors.initials: A
authors.lastname: Meneghelli
mesh_terms: D000328:Adult; D019090:Case Management; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003155:Community Mental Health Centers; D005196:Family Therapy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011618:Psychotic Disorders / Q000628:therapy*
keywords: cognitive behavioral therapy; early psychosis; family intervention; outcome assessment; schizophrenia