Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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.
Mirella Ruggeri, Chiara Bonetto, Antonio Lasalvia, Giovanni De Girolamo, Angelo Fioritti, Paola Rucci, Paolo Santonastaso, Giovanni Neri, Francesca Pileggi, Daniela Ghigi, Maurizio Miceli, Silvio Scarone, Angelo Cocchi, Stefano Torresani, Carlo Faravelli, Christa Zimmermann, Anna Meneghelli, Carla Cremonese, Paolo Scocco, Emanuela Leuci, Fausto Mazzi, Massimo Gennarelli, Paolo Brambilla, Sarah Bissoli, Maria Elena Bertani, Sarah Tosato, Katia De Santi, Sara Poli, Doriana Cristofalo, Michele Tansella, Mirella Ruggeri, Maria Elena Mirella, Sarah Bissoli, Chiara Bonetto, Doriana Cristofalo, Katia De Santi, Antonio Lasalvia, Silvia Lunardi, Valentina Negretto, Sara Poli, Sarah Tosato, Maria Grazia Zamboni, Mario Ballarin, Giovanni De Girolamo, Angelo Fioritti, Giovanni Neri, Francesca Pileggi, Paola Rucci, Luisella Bocchio Chiavetto, Catia Scasselatti, Roberta Zanardini, Paolo Brambilla, Marcella Bellani, Alessandra Bertoldo, Veronica Marinelli, Valentina Negretto, Cinzia Perlini, Gianluca Rambaldelli, Antonio Lasalvia, Mariaelena Bertani, Sarah Bissoli, Lorenza Lazzarotto, Sonia Bardella, Francesco Gardellin, Dario Lamonaca, Antonio Lasalvia, Marco Lunardon, Renato Magnabosco, Marilena Martucci, Stylianos Nicolau, Francesco Nifosì, Michele Pavanati, Massimo Rossi, Carlo Piazza, Gabriella Piccione, Alessandra Sala, Annalisa Sale, Benedetta Stefan, Spyridon Zotos, Mirko Balbo, Ileana Boggian, Enrico Ceccato, Rosa Dall'Agnola, Francesco Gardellin, Barbara Girotto, Claudia Goss, Dario Lamonaca, Antonio Lasalvia, Roberta Leoni, Alessia Mai, Annalisa Pasqualini, Michele Pavanati, Carlo Piazza, Gabriella Piccione, Stefano Roccato, Alberto Rossi, Annalisa Sale, Stefania Strizzolo, Spyridon Zotos, Anna Urbani, Flavia Ald, Barbara Bianchi, Paola Cappellari, Raffaello Conti, Laura De Battisti, Ermanna Lazzarin, Silvia Merlin, Giuseppe Migliorini, Tecla Pozzan, Lucio Sarto, Stefania Visonà, Andrea Brazzoli, Antonella Campi, Roberta Carmagnani, Sabrina Giambelli, Annalisa Gianella, Lino Lunardi, Davide Madaghiele, Paola Maestrelli, Lidia Paiola, Elisa Posteri, Loretta Viola, Valentina Zamberlan, Marta Zenari, Sarah Tosato, Martina Zanoni, Giovanni Bonadonna, Mariacristina Bonomo, Paolo Santonastaso, Carla Cremonese, Paolo Scocco, Angela Veronese, Patrizia Anderle, Andrea Angelozz, Isabelle Amalric, Gabriella Baron, Enrico Bruttomesso Fabio Candeago, Franco Castelli, Maria Chieco, Carla Cremonese, Enrico Di Costanzo, Mario Derossi, Michele Doriguzzi, Osvaldo Galvano, Marcello Lattanz, Roberto Lezzi, Marisa Marcato, Alessandro Marcolin, Franco Marini, Manlio Matranga, Donato Scalabrin, Maria Zucchetto, Flavio Zadro, Giovanni Austoni, Maria Bianco, Francesca Bordino, Filippo Dario, Alessandro De Risio, Aldo Gatto, Simona Granà, Emanuele Favero, Anna Franceschin, Silvia Friederici, Vanna Marangon, Michela Pascolo, Luana Ramon, Paolo Scocco, Angela Veronese, Stefania Zambolin, Rossana Riolo, Antonella Buffon, Carla Cremonese, Elena Di Bortolo, Silvia Friederici, Stefania Fortin, Marisa Marcato, Francesco Matarrese, Simona Mogni, Novella Codemo, Alessio Russi, Alessandra Silvestro, Elena Turella, Paola Viel, Anna Dominoni, Lorenzo Andreose, Mario Boemio, Loretta Bressan, Arianna Cabbia, Elisabetta Canesso, Romina Cian, Claudia Dal Piccol, Maria Manuela Dalla Pasqua, Anna Di Prisco, Lorena Mantellato, Monica Luison, Sandra Morgante, Mirna Santi, Moreno Sacillotto, Mauro Scabbio, Patrizia Sponga, M Luisa Sguotto, Flavia Stach, M Grazia Vettorato, Giorgio Martinello, Francesca Dassiè, Stefano Marino, Linda Cibiniel, Ilenia Masetto, Marisa Marcato, Oscar Cabianca, Amalia Valente, Livio Caberlotto, Alberto Passoni, Patrizia Flumian, Luigino Daniel, Massimo Gion, Stanziale Stanziale, Flora Alborino, Vladimiro Bortolozzo, Lucio Bacelle, Leonarda Bicciato, Daniela Basso, Filippo Navaglia, Fabio Manoni, Mauro Ercolin, Giovanni Neri, Franco Giubilini, Massimiliano Imbesi, Emanuela Leuci, Fausto Mazzi, Enrico Semrov, Castel S Giovanni, Valli Taro e Ceno, Polo Ovest, Silvio Anelli, Mario Amore, Laura Bigi, Welsch Britta, Giovanna Barazzoni Anna, Uobes Bonatti, Maria Borziani, Isabella Crosato, Raffaele Galluccio, Margherita Galeotti, Mauro Gozzi, Vanna Greco, Emanuele Guagnini, Stefania Pagani, Malvasi Maccherozzi, Francesco Marchi, Ermanno Melato, Elena Mazzucchi, Franco Marzullo, Pietro Pellegrini, Nicoletta Petrolini, Paolo Volta, Silvio Anelli, Franca Bonara, Elisabetta Brusamonti, Roberto Croci, Ivana Flamia, Francesca Fontana, Romina Losi, Fausto Mazzi, Roberto Marchioro, Stefania Pagani, Luigi Raffaini, Luca Ruju, Antonio Saginario, M Grazia Tondelli, Donatella Marrama, Lucia Bernardelli, Federica Bonacini, Annaluisa Florindo, Marina Merli, Patrizia Nappo, Lorena Sola, Ornella Tondelli, Matteo Tonna, M Teresa Torre, Morena Tosatti, Gloria Venturelli, Daria Zampolla, Antonia Bernardi, Cinzia Cavalli, Lorena Cigala, Cinzia Ciraudo, Antonia Di Bari, Lorena Ferri, Fabiana Gombi, Sonia Leurini, Elena Mandatelli, Stefano Maccaferri, Mara Oroboncoide, Barbara Pisa, Cristina Ricci, Enrica Poggi, Corrado Zurlini, Monica Malpeli, Rossana Colla, Elvira Teodori, Luigi Vecchia, Rocco D'Andrea, Tommaso Trenti, Paola Paolini, Fausto Mazzi, Paolo Carpeggiani, Francesca Pileggi, Daniela Ghigi, Mariateresa Gagliostro, Michela Pratelli, Paola Rucci, S Lazzaro, Antonio Antonelli, Luana Battistini, Francesca Bellini, Eva Bonini, Caterina Bruschi Rossella Capelli, Cinzia DiDomizio, Chiara Drei, Giuseppe Fucci, Alessandra Gualandi, Maria Rosaria Grazia, Anna M Losi, Federica Mazzanti Paola Mazzoni, Daniela Marangoni, Giuseppe Monna, Marco Morselli, Alessandro Oggioni, Silvio Oprandi, Walter Paganelli, Morena Passerini, Maria Piscitelli, Gregorio Reggiani, Gabriella Rossi, Federica Salvatori, Simona Trasforini, Carlo Uslenghi, Simona Veggetti, Giovanna Bartolucci, Rosita Baruffa, Francesca Bellini, Raffaella Bertelli, Lidia Borghi, Patrizia Ciavarella, Cinzia DiDomizio, Giuseppe Monna, Alessandro Oggioni, Elisabetta Paltrinieri, Francesco Rizzardi, Piera Serra, Damiano Suzzi, Uslenghi Carlo, Maria Piscitelli, Paolo Arienti, Fabio Aureli, Rosita Avanzi, Vincenzo Callegari, Alessandra Corsino, Paolo Host, Rossella Michetti, Michela Pratelli, Francesco Rizzo, Paola Simoncelli, Elena Soldati, Eraldo Succi, Massimo Bertozzi, Elisa Canetti, Luca Cavicchioli, Elisa Ceccarelli, Stefano Cenni, Glenda Marzola, Vanessa Gallina, Carla Leoni, Andrea Olivieri, Elena Piccolo, Sabrina Ravagli, Rosaria Russo, Daniele Tedeschini, Marina Verenini, Walter Abram, Veronica Granata, Alessandro Curcio, Giovanni Guerra, Samuela Granini, Lara Natali, Enrica Montanari, Fulvia Pasi, Umbertina Ventura, Stefania Valenti, Masi Francesca, Rossano Farneti, Paolo Ravagli, Romina Floris, Otello Maroncelli, Gianbattista Volpones, Donatella Casali, Maurizio Miceli, Andrea Bencini, Massimo Cellini, Luca De Biase, Leonardo Barbara, Liedl Charles, Cristina Pratesi, Andrea Tanini, Massimo Cellini, Maurizio Miceli, Riccardo Loparrino, Cristina Pratesi, Cinzia Ulivelli, Cristina Cussoto, Nico Dei, Enrico Fumanti, Manuela Pantani, Gregorio Zeloni, Rossella Bellini, Roberta Cellesi, Nadia Dorigo, Patrizia Gullì, Luisa Ialeggio, Maria Pisanu, Graziella Rinaldi, Angela Konze, Angelo Cocchi, Anna Meneghelli, Mario Bianco, Litta Modignani, Maria Frova, Emiliano Monzani, Alberto Zanobio, Marina Malagoli, Roberto Pagani, Simona Barbera, Carla Morganti, Emiliano Monzani, Elisabetta Sarzi Amadè, Virginia Brambilla, Anita Montanari, Giori Caterina, Carmelo Lopez, Alessandro Marocchi, Andrea Moletta, Maurizio Sberna, M Teresa Cascio, Silvio Scarone, Maria Laura Manzone, Barbera Barbara, Luisa Mari, Maria L Manzone, Edoardo Razzini, Yvonne Bianchi, M Rosa Pellizzer, Antonella Verdecchia, M Gabriella Sferrazza, M Laura Manzone, Rosa Pismataro, Gian Vico Melzi D'Eril, Alessandra Barassi, Rosana Pacciolla, Gloria Faraci, Stefano Torresani, Bolzano Rosmini, Fabio Carpi, Margit Soelva, Monica Anderlan, Michele De Francesco, Efi Duregger, Stefano Torresani, Carla Vettori, Sabrina Doimo, Erika Kompatscher, Margit Soelva, Stefano Torresani, Michael Forer, Helene Kerschbaumer, Anna Gampe, Maira Nicoletti, Chiara Acerbi, Daniele Aquilino, Silvia Azzali, Luca Bensi, Sarah Bissoli, Davide Cappellari, Elisa Casana, Nadia Campagnola, Elisa Dal Corso, Elisabetta Di Micco, Erika Gobbi, Laura Ferri, Erika Gobbi, Laura Mairaghi, Sara Malak, Luca Mesiano, Federica Paterlini, Michela Perini, Elena Maria Puliti, Rosaria Rispoli, Elisabetta Rizzo, Chiara Sergenti, Manuela Soave, Andrea Alpi, Laura Bislenghi, Tiziana Bolis, Francesca Colnaghi, Simona Fascendini, Silvia Grignani, Anna Meneghelli, Giovanni Patelli, Carlo Faravelli, Silvia Casale, Christa Zimmermann, Giuseppe Deledda, Claudia Goss, Mariangela Mazzi, Michela Rimondini, Massimo Gennarelli, Catia Scassellati, Cristian Bonvicini, Sara Longo, Luisella Bocchio Chiavetto, Roberta Zanardini, Mariacarla Ventriglia, Rosanna Squitti, Giovanni Frisoni, Michela Pievani, Matteo Balestrieri, Paolo Brambilla, Cinzia Perlini, Veronica Marinelli, Marcella Bellani, Gianluca Rambaldelli, Alessandra Bertoldo, Manfredo Atzori, Fausto Mazzi, Paolo Carpeggiani, Alberto Beltramello, Franco Alessandrini, Francesca Pizzini, Giada Zoccatelli, Maurizio Sberna, Angela Konze, Pierluigi Politi, Enzo Emanuele, Natascia Brondino, Gianvito Martino, Alessandra Bergami, Roberto Zarbo, Marco Andrea Riva, Fabio Fumagalli, Raffaella Molteni, Francesca Calabrese, Gianluigi Guidotti, Alessia Luoni, Flavia Macchi, Stefania Artioli, Marco Baldetti, Milena Bizzocchi, Donatella Bolzon, Elisa Bonello, Giorgia Cacciari, Claudia Carraresi, M Teresa Cascio, Gabriele Caselli, Karin Furlato, Sara Garlassi, Alessandro Gavarini, Silvia Lunardi, Fabio Macchetti, Valentina Marteddu, Giorgia Plebiscita, Sara Poli, Stefano Totaro, Paul Bebbington, Max Birchwood, Paola Dazzan, Elisabeth Kuipers, Graham Thornicroft, Carmine Pariante, Steve Lawrie, Carmine Pariante, Jair C SoaresBACKGROUND: 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.
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