1. A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.
- Author
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Ruggeri M, Bonetto C, Lasalvia A, De Girolamo G, Fioritti A, Rucci P, Santonastaso P, Neri G, Pileggi F, Ghigi D, Miceli M, Scarone S, Cocchi A, Torresani S, Faravelli C, Zimmermann C, Meneghelli A, Cremonese C, Scocco P, Leuci E, Mazzi F, Gennarelli M, Brambilla P, Bissoli S, Bertani ME, Tosato S, De Santi K, Poli S, Cristofalo D, Tansella M, Ruggeri M, Mirella ME, Bissoli S, Bonetto C, Cristofalo D, De Santi K, Lasalvia A, Lunardi S, Negretto V, Poli S, Tosato S, Zamboni MG, Ballarin M, De Girolamo G, Fioritti A, Neri G, Pileggi F, Rucci P, Bocchio Chiavetto L, Scasselatti C, Zanardini R, Brambilla P, Bellani M, Bertoldo A, Marinelli V, Negretto V, Perlini C, Rambaldelli G, Lasalvia A, Bertani M, Bissoli S, Lazzarotto L, Bardella S, Gardellin F, Lamonaca D, Lasalvia A, Lunardon M, Magnabosco R, Martucci M, Nicolau S, Nifosì F, Pavanati M, Rossi M, Piazza C, Piccione G, Sala A, Sale A, Stefan B, Zotos S, Balbo M, Boggian I, Ceccato E, Dall'Agnola R, Gardellin F, Girotto B, Goss C, Lamonaca D, Lasalvia A, Leoni R, Mai A, Pasqualini A, Pavanati M, Piazza C, Piccione G, Roccato S, Rossi A, Sale A, Strizzolo S, Zotos S, Urbani A, Ald F, Bianchi B, Cappellari P, Conti R, De Battisti L, Lazzarin E, Merlin S, Migliorini G, Pozzan T, Sarto L, Visonà S, Brazzoli A, Campi A, Carmagnani R, Giambelli S, Gianella A, Lunardi L, Madaghiele D, Maestrelli P, Paiola L, Posteri E, Viola L, Zamberlan V, Zenari M, Tosato S, Zanoni M, Bonadonna G, Bonomo M, Santonastaso P, Cremonese C, Scocco P, Veronese A, Anderle P, Angelozz A, Amalric I, Baron G, Candeago EB, Castelli F, Chieco M, Cremonese C, Di Costanzo E, Derossi M, Doriguzzi M, Galvano O, Lattanz M, Lezzi R, Marcato M, Marcolin A, Marini F, Matranga M, Scalabrin D, Zucchetto M, Zadro F, Austoni G, Bianco M, Bordino F, Dario F, De Risio A, Gatto A, Granà S, Favero E, Franceschin A, Friederici S, Marangon V, Pascolo M, Ramon L, Scocco P, Veronese A, Zambolin S, Riolo R, Buffon A, Cremonese C, Di Bortolo E, Friederici S, Fortin S, Marcato M, Matarrese F, Mogni S, Codemo N, Russi A, Silvestro A, Turella E, Viel P, Dominoni A, Andreose L, Boemio M, Bressan L, Cabbia A, Canesso E, Cian R, Dal Piccol C, Dalla Pasqua MM, Di Prisco A, Mantellato L, Luison M, Morgante S, Santi M, Sacillotto M, Scabbio M, Sponga P, Sguotto ML, Stach F, Vettorato MG, Martinello G, Dassiè F, Marino S, Cibiniel L, Masetto I, Marcato M, Cabianca O, Valente A, Caberlotto L, Passoni A, Flumian P, Daniel L, Gion M, Stanziale S, Alborino F, Bortolozzo V, Bacelle L, Bicciato L, Basso D, Navaglia F, Manoni F, Ercolin M, Neri G, Giubilini F, Imbesi M, Leuci E, Mazzi F, Semrov E, Giovanni CS, Taro e Ceno V, Ovest P, Anelli S, Amore M, Bigi L, Britta W, Anna GB, Bonatti U, Borziani M, Crosato I, Galluccio R, Galeotti M, Gozzi M, Greco V, Guagnini E, Pagani S, Maccherozzi M, Marchi F, Melato E, Mazzucchi E, Marzullo F, Pellegrini P, Petrolini N, Volta P, Anelli S, Bonara F, Brusamonti E, Croci R, Flamia I, Fontana F, Losi R, Mazzi F, Marchioro R, Pagani S, Raffaini L, Ruju L, Saginario A, Tondelli MG, Marrama D, Bernardelli L, Bonacini F, Florindo A, Merli M, Nappo P, Sola L, Tondelli O, Tonna M, Torre MT, Tosatti M, Venturelli G, Zampolla D, Bernardi A, Cavalli C, Cigala L, Ciraudo C, Di Bari A, Ferri L, Gombi F, Leurini S, Mandatelli E, Maccaferri S, Oroboncoide M, Pisa B, Ricci C, Poggi E, Zurlini C, Malpeli M, Colla R, Teodori E, Vecchia L, D'Andrea R, Trenti T, Paolini P, Mazzi F, Carpeggiani P, Pileggi F, Ghigi D, Gagliostro M, Pratelli M, Rucci P, Lazzaro S, Antonelli A, Battistini L, Bellini F, Bonini E, Capelli CB, DiDomizio C, Drei C, Fucci G, Gualandi A, Grazia MR, Losi AM, Mazzoni FM, Marangoni D, Monna G, Morselli M, Oggioni A, Oprandi S, Paganelli W, Passerini M, Piscitelli M, Reggiani G, Rossi G, Salvatori F, Trasforini S, Uslenghi C, Veggetti S, Bartolucci G, Baruffa R, Bellini F, Bertelli R, Borghi L, Ciavarella P, DiDomizio C, Monna G, Oggioni A, Paltrinieri E, Rizzardi F, Serra P, Suzzi D, Carlo U, Piscitelli M, Arienti P, Aureli F, Avanzi R, Callegari V, Corsino A, Host P, Michetti R, Pratelli M, Rizzo F, Simoncelli P, Soldati E, Succi E, Bertozzi M, Canetti E, Cavicchioli L, Ceccarelli E, Cenni S, Marzola G, Gallina V, Leoni C, Olivieri A, Piccolo E, Ravagli S, Russo R, Tedeschini D, Verenini M, Abram W, Granata V, Curcio A, Guerra G, Granini S, Natali L, Montanari E, Pasi F, Ventura U, Valenti S, Francesca M, Farneti R, Ravagli P, Floris R, Maroncelli O, Volpones G, Casali D, Miceli M, Bencini A, Cellini M, De Biase L, Barbara L, Charles L, Pratesi C, Tanini A, Cellini M, Miceli M, Loparrino R, Pratesi C, Ulivelli C, Cussoto C, Dei N, Fumanti E, Pantani M, Zeloni G, Bellini R, Cellesi R, Dorigo N, Gullì P, Ialeggio L, Pisanu M, Rinaldi G, Konze A, Cocchi A, Meneghelli A, Bianco M, Modignani L, Frova M, Monzani E, Zanobio A, Malagoli M, Pagani R, Barbera S, Morganti C, Monzani E, Amadè ES, Brambilla V, Montanari A, Caterina G, Lopez C, Marocchi A, Moletta A, Sberna M, Cascio MT, Scarone S, Manzone ML, Barbara B, Mari L, Manzone ML, Razzini E, Bianchi Y, Pellizzer MR, Verdecchia A, Sferrazza MG, Manzone ML, Pismataro R, D'Eril GV, Barassi A, Pacciolla R, Faraci G, Torresani S, Rosmini B, Carpi F, Soelva M, Anderlan M, De Francesco M, Duregger E, Torresani S, Vettori C, Doimo S, Kompatscher E, Soelva M, Torresani S, Forer M, Kerschbaumer H, Gampe A, Nicoletti M, Acerbi C, Aquilino D, Azzali S, Bensi L, Bissoli S, Cappellari D, Casana E, Campagnola N, Dal Corso E, Di Micco E, Gobbi E, Ferri L, Gobbi E, Mairaghi L, Malak S, Mesiano L, Paterlini F, Perini M, Puliti EM, Rispoli R, Rizzo E, Sergenti C, Soave M, Alpi A, Bislenghi L, Bolis T, Colnaghi F, Fascendini S, Grignani S, Meneghelli A, Patelli G, Faravelli C, Casale S, Zimmermann C, Deledda G, Goss C, Mazzi M, Rimondini M, Gennarelli M, Scassellati C, Bonvicini C, Longo S, Bocchio Chiavetto L, Zanardini R, Ventriglia M, Squitti R, Frisoni G, Pievani M, Balestrieri M, Brambilla P, Perlini C, Marinelli V, Bellani M, Rambaldelli G, Bertoldo A, Atzori M, Mazzi F, Carpeggiani P, Beltramello A, Alessandrini F, Pizzini F, Zoccatelli G, Sberna M, Konze A, Politi P, Emanuele E, Brondino N, Martino G, Bergami A, Zarbo R, Riva MA, Fumagalli F, Molteni R, Calabrese F, Guidotti G, Luoni A, Macchi F, Artioli S, Baldetti M, Bizzocchi M, Bolzon D, Bonello E, Cacciari G, Carraresi C, Cascio MT, Caselli G, Furlato K, Garlassi S, Gavarini A, Lunardi S, Macchetti F, Marteddu V, Plebiscita G, Poli S, Totaro S, Bebbington P, Birchwood M, Dazzan P, Kuipers E, Thornicroft G, Pariante C, Lawrie S, Pariante C, and Soares JC
- Subjects
- Cluster Analysis, Community Mental Health Centers, Humans, Italy, Patient Selection, Psychotic Disorders diagnosis, Psychotic Disorders psychology, Recurrence, Sample Size, Severity of Illness Index, Time Factors, Treatment Outcome, Case Management, Cognitive Behavioral Therapy, Community Mental Health Services, Family Relations, Psychotic Disorders therapy, Research Design
- Abstract
Background: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services., Methods/design: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.
- Published
- 2012
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