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 enrolment 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.Trial registration: ClinicalTrials.gov Identifier NCT01436331.
| Original language | English |
|---|---|
| Article number | 1745 |
| Journal | Trials |
| Volume | 13 |
| DOIs | |
| Publication status | Published - May 30 2012 |
Keywords
- Family intervention
- First-episode psychosisEarly psychosisCognitive behavioral therapyPsychosocial interventionAssertive community treatment
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)
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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. / Ruggeri, Mirella; Bonetto, Chiara; Lasalvia, Antonio; De Girolamo, Giovanni; Fioritti, Angelo; Rucci, Paola; Santonastaso, Paolo; Neri, Giovanni; Pileggi, Francesca; Ghigi, Daniela; Miceli, Maurizio; Scarone, Silvio; Cocchi, Angelo; Torresani, Stefano; Faravelli, Carlo; Zimmermann, Christa; Meneghelli, Anna; Cremonese, Carla; Scocco, Paolo; Leuci, Emanuela; Mazzi, Fausto; Gennarelli, Massimo; Brambilla, Paolo; Bissoli, Sarah; Bertani, Maria E.; Tosato, Sarah; De Santi, Katia; Poli, Sara; Cristofalo, Doriana; Tansella, Michele; Ruggeri, Mirella; Ruggeri, Mirella; Bertani, Maria Elena; Bissoli, Sarah; Bonetto, Chiara; Cristofalo, Doriana; De Santi, Katia; Lasalvia, Antonio; Lunardi, Silvia; Negretto, Valentina; Poli, Sara; Tosato, Sarah; Zamboni, Maria Grazia; Ballarin, Mario; De Girolamo, Giovanni; Fioritti, Angelo; Neri, Giovanni; Pileggi, Francesca; Rucci, Paola; Gennarelli, Massimo; Chiavetto, Luisella Bocchio; Scasselatti, Catia; Brambilla, Paolo; Bellani, Marcella; Bertoldo, Alessandra; Marinelli, Veronica; Negretto, Valentina; Perlini, Cinzia; Rambaldelli, Gianluca; 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, E. B.; 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, M. M.; Di Prisco, A.; Mantellato, L.; Luison, M.; Morgante, S.; Santi, M.; Sacillotto, M.; Scabbio, M.; Sponga, P.; Sguotto, M. L.; Stach, F.; Vettorato, M. G.; 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, C. S.; Taro e Ceno, V.; Ovest, P.; Anelli, S.; Amore, M.; Bigi, L.; Britta, W.; Anna, G. B.; 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, M. G.; Marrama, D.; Bernardelli, L.; Bonacini, F.; Florindo, A.; Merli, M.; Nappo, P.; Sola, L.; Tondelli, O.; Tonna, M.; Torre, M. T.; 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, C. B.; DiDomizio, C.; Drei, C.; Fucci, G.; Gualandi, A.; Grazia, M. R.; Losi, A. M.; Mazzoni, F. M.; 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, E. S.; Brambilla, V.; Montanari, A.; Caterina, G.; Lopez, C.; Marocchi, A.; Moletta, A.; Sberna, M.; Cascio, M. T.; Scarone, S.; Manzone, M. L.; Barbara, B.; Mari, L.; Manzone, M. L.; Razzini, E.; Bianchi, Y.; Pellizzer, M. R.; Verdecchia, A.; Sferrazza, M. G.; Manzone, M. L.; Pismataro, R.; D'Eril, G. V.; 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, E. M.; 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, M. A.; 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, M. T.; 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.; Soares, J. C.
In: Trials, Vol. 13, 1745, 30.05.2012.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants
T2 - study protocol for a pragmatic cluster randomized controlled trial
AU - Ruggeri, Mirella
AU - Bonetto, Chiara
AU - Lasalvia, Antonio
AU - De Girolamo, Giovanni
AU - Fioritti, Angelo
AU - Rucci, Paola
AU - Santonastaso, Paolo
AU - Neri, Giovanni
AU - Pileggi, Francesca
AU - Ghigi, Daniela
AU - Miceli, Maurizio
AU - Scarone, Silvio
AU - Cocchi, Angelo
AU - Torresani, Stefano
AU - Faravelli, Carlo
AU - Zimmermann, Christa
AU - Meneghelli, Anna
AU - Cremonese, Carla
AU - Scocco, Paolo
AU - Leuci, Emanuela
AU - Mazzi, Fausto
AU - Gennarelli, Massimo
AU - Brambilla, Paolo
AU - Bissoli, Sarah
AU - Bertani, Maria E.
AU - Tosato, Sarah
AU - De Santi, Katia
AU - Poli, Sara
AU - Cristofalo, Doriana
AU - Tansella, Michele
AU - Ruggeri, Mirella
AU - Ruggeri, Mirella
AU - Bertani, Maria Elena
AU - Bissoli, Sarah
AU - Bonetto, Chiara
AU - Cristofalo, Doriana
AU - De Santi, Katia
AU - Lasalvia, Antonio
AU - Lunardi, Silvia
AU - Negretto, Valentina
AU - Poli, Sara
AU - Tosato, Sarah
AU - Zamboni, Maria Grazia
AU - Ballarin, Mario
AU - De Girolamo, Giovanni
AU - Fioritti, Angelo
AU - Neri, Giovanni
AU - Pileggi, Francesca
AU - Rucci, Paola
AU - Gennarelli, Massimo
AU - Chiavetto, Luisella Bocchio
AU - Scasselatti, Catia
AU - Brambilla, Paolo
AU - Bellani, Marcella
AU - Bertoldo, Alessandra
AU - Marinelli, Veronica
AU - Negretto, Valentina
AU - Perlini, Cinzia
AU - Rambaldelli, Gianluca
AU - Pasqualini, A.
AU - Pavanati, M.
AU - Piazza, C.
AU - Piccione, G.
AU - Roccato, S.
AU - Rossi, A.
AU - Sale, A.
AU - Strizzolo, S.
AU - Zotos, S.
AU - Urbani, A.
AU - Ald, F.
AU - Bianchi, B.
AU - Cappellari, P.
AU - Conti, R.
AU - De Battisti, L.
AU - Lazzarin, E.
AU - Merlin, S.
AU - Migliorini, G.
AU - Pozzan, T.
AU - Sarto, L.
AU - Visonà, S.
AU - Brazzoli, A.
AU - Campi, A.
AU - Carmagnani, R.
AU - Giambelli, S.
AU - Gianella, A.
AU - Lunardi, L.
AU - Madaghiele, D.
AU - Maestrelli, P.
AU - Paiola, L.
AU - Posteri, E.
AU - Viola, L.
AU - Zamberlan, V.
AU - Zenari, M.
AU - Tosato, S.
AU - Zanoni, M.
AU - Bonadonna, G.
AU - Bonomo, M.
AU - Santonastaso, P.
AU - Cremonese, C.
AU - Scocco, P.
AU - Veronese, A.
AU - Anderle, P.
AU - Angelozz, A.
AU - Amalric, I.
AU - Baron, G.
AU - Candeago, E. B.
AU - Castelli, F.
AU - Chieco, M.
AU - Cremonese, C.
AU - Di Costanzo, E.
AU - Derossi, M.
AU - Doriguzzi, M.
AU - Galvano, O.
AU - Lattanz, M.
AU - Lezzi, R.
AU - Marcato, M.
AU - Marcolin, A.
AU - Marini, F.
AU - Matranga, M.
AU - Scalabrin, D.
AU - Zucchetto, M.
AU - Zadro, F.
AU - Austoni, G.
AU - Bianco, M.
AU - Bordino, F.
AU - Dario, F.
AU - De Risio, A.
AU - Gatto, A.
AU - Granà, S.
AU - Favero, E.
AU - Franceschin, A.
AU - Friederici, S.
AU - Marangon, V.
AU - Pascolo, M.
AU - Ramon, L.
AU - Scocco, P.
AU - Veronese, A.
AU - Zambolin, S.
AU - Riolo, R.
AU - Buffon, A.
AU - Cremonese, C.
AU - Di Bortolo, E.
AU - Friederici, S.
AU - Fortin, S.
AU - Marcato, M.
AU - Matarrese, F.
AU - Mogni, S.
AU - Codemo, N.
AU - Russi, A.
AU - Silvestro, A.
AU - Turella, E.
AU - Viel, P.
AU - Dominoni, A.
AU - Andreose, L.
AU - Boemio, M.
AU - Bressan, L.
AU - Cabbia, A.
AU - Canesso, E.
AU - Cian, R.
AU - Dal Piccol, C.
AU - Dalla Pasqua, M. M.
AU - Di Prisco, A.
AU - Mantellato, L.
AU - Luison, M.
AU - Morgante, S.
AU - Santi, M.
AU - Sacillotto, M.
AU - Scabbio, M.
AU - Sponga, P.
AU - Sguotto, M. L.
AU - Stach, F.
AU - Vettorato, M. G.
AU - Martinello, G.
AU - Dassiè, F.
AU - Marino, S.
AU - Cibiniel, L.
AU - Masetto, I.
AU - Marcato, M.
AU - Cabianca, O.
AU - Valente, A.
AU - Caberlotto, L.
AU - Passoni, A.
AU - Flumian, P.
AU - Daniel, L.
AU - Gion, M.
AU - Stanziale, S.
AU - Alborino, F.
AU - Bortolozzo, V.
AU - Bacelle, L.
AU - Bicciato, L.
AU - Basso, D.
AU - Navaglia, F.
AU - Manoni, F.
AU - Ercolin, M.
AU - Neri, G.
AU - Giubilini, F.
AU - Imbesi, M.
AU - Leuci, E.
AU - Mazzi, F.
AU - Semrov, E.
AU - Giovanni, C. S.
AU - Taro e Ceno, V.
AU - Ovest, P.
AU - Anelli, S.
AU - Amore, M.
AU - Bigi, L.
AU - Britta, W.
AU - Anna, G. B.
AU - Bonatti, U.
AU - Borziani, M.
AU - Crosato, I.
AU - Galluccio, R.
AU - Galeotti, M.
AU - Gozzi, M.
AU - Greco, V.
AU - Guagnini, E.
AU - Pagani, S.
AU - Maccherozzi, M.
AU - Marchi, F.
AU - Melato, E.
AU - Mazzucchi, E.
AU - Marzullo, F.
AU - Pellegrini, P.
AU - Petrolini, N.
AU - Volta, P.
AU - Anelli, S.
AU - Bonara, F.
AU - Brusamonti, E.
AU - Croci, R.
AU - Flamia, I.
AU - Fontana, F.
AU - Losi, R.
AU - Mazzi, F.
AU - Marchioro, R.
AU - Pagani, S.
AU - Raffaini, L.
AU - Ruju, L.
AU - Saginario, A.
AU - Tondelli, M. G.
AU - Marrama, D.
AU - Bernardelli, L.
AU - Bonacini, F.
AU - Florindo, A.
AU - Merli, M.
AU - Nappo, P.
AU - Sola, L.
AU - Tondelli, O.
AU - Tonna, M.
AU - Torre, M. T.
AU - Tosatti, M.
AU - Venturelli, G.
AU - Zampolla, D.
AU - Bernardi, A.
AU - Cavalli, C.
AU - Cigala, L.
AU - Ciraudo, C.
AU - Di Bari, A.
AU - Ferri, L.
AU - Gombi, F.
AU - Leurini, S.
AU - Mandatelli, E.
AU - Maccaferri, S.
AU - Oroboncoide, M.
AU - Pisa, B.
AU - Ricci, C.
AU - Poggi, E.
AU - Zurlini, C.
AU - Malpeli, M.
AU - Colla, R.
AU - Teodori, E.
AU - Vecchia, L.
AU - D'Andrea, R.
AU - Trenti, T.
AU - Paolini, P.
AU - Mazzi, F.
AU - Carpeggiani, P.
AU - Pileggi, F.
AU - Ghigi, D.
AU - Gagliostro, M.
AU - Pratelli, M.
AU - Rucci, P.
AU - Lazzaro, S.
AU - Antonelli, A.
AU - Battistini, L.
AU - Bellini, F.
AU - Bonini, E.
AU - Capelli, C. B.
AU - DiDomizio, C.
AU - Drei, C.
AU - Fucci, G.
AU - Gualandi, A.
AU - Grazia, M. R.
AU - Losi, A. M.
AU - Mazzoni, F. M.
AU - Marangoni, D.
AU - Monna, G.
AU - Morselli, M.
AU - Oggioni, A.
AU - Oprandi, S.
AU - Paganelli, W.
AU - Passerini, M.
AU - Piscitelli, M.
AU - Reggiani, G.
AU - Rossi, G.
AU - Salvatori, F.
AU - Trasforini, S.
AU - Uslenghi, C.
AU - Veggetti, S.
AU - Bartolucci, G.
AU - Baruffa, R.
AU - Bellini, F.
AU - Bertelli, R.
AU - Borghi, L.
AU - Ciavarella, P.
AU - DiDomizio, C.
AU - Monna, G.
AU - Oggioni, A.
AU - Paltrinieri, E.
AU - Rizzardi, F.
AU - Serra, P.
AU - Suzzi, D.
AU - Carlo, U.
AU - Piscitelli, M.
AU - Arienti, P.
AU - Aureli, F.
AU - Avanzi, R.
AU - Callegari, V.
AU - Corsino, A.
AU - Host, P.
AU - Michetti, R.
AU - Pratelli, M.
AU - Rizzo, F.
AU - Simoncelli, P.
AU - Soldati, E.
AU - Succi, E.
AU - Bertozzi, M.
AU - Canetti, E.
AU - Cavicchioli, L.
AU - Ceccarelli, E.
AU - Cenni, S.
AU - Marzola, G.
AU - Gallina, V.
AU - Leoni, C.
AU - Olivieri, A.
AU - Piccolo, E.
AU - Ravagli, S.
AU - Russo, R.
AU - Tedeschini, D.
AU - Verenini, M.
AU - Abram, W.
AU - Granata, V.
AU - Curcio, A.
AU - Guerra, G.
AU - Granini, S.
AU - Natali, L.
AU - Montanari, E.
AU - Pasi, F.
AU - Ventura, U.
AU - Valenti, S.
AU - Francesca, M.
AU - Farneti, R.
AU - Ravagli, P.
AU - Floris, R.
AU - Maroncelli, O.
AU - Volpones, G.
AU - Casali, D.
AU - Miceli, M.
AU - Bencini, A.
AU - Cellini, M.
AU - De Biase, L.
AU - Barbara, L.
AU - Charles, L.
AU - Pratesi, C.
AU - Tanini, A.
AU - Cellini, M.
AU - Miceli, M.
AU - Loparrino, R.
AU - Pratesi, C.
AU - Ulivelli, C.
AU - Cussoto, C.
AU - Dei, N.
AU - Fumanti, E.
AU - Pantani, M.
AU - Zeloni, G.
AU - Bellini, R.
AU - Cellesi, R.
AU - Dorigo, N.
AU - Gullì, P.
AU - Ialeggio, L.
AU - Pisanu, M.
AU - Rinaldi, G.
AU - Konze, A.
AU - Cocchi, A.
AU - Meneghelli, A.
AU - Bianco, M.
AU - Modignani, L.
AU - Frova, M.
AU - Monzani, E.
AU - Zanobio, A.
AU - Malagoli, M.
AU - Pagani, R.
AU - Barbera, S.
AU - Morganti, C.
AU - Monzani, E.
AU - Amadè, E. S.
AU - Brambilla, V.
AU - Montanari, A.
AU - Caterina, G.
AU - Lopez, C.
AU - Marocchi, A.
AU - Moletta, A.
AU - Sberna, M.
AU - Cascio, M. T.
AU - Scarone, S.
AU - Manzone, M. L.
AU - Barbara, B.
AU - Mari, L.
AU - Manzone, M. L.
AU - Razzini, E.
AU - Bianchi, Y.
AU - Pellizzer, M. R.
AU - Verdecchia, A.
AU - Sferrazza, M. G.
AU - Manzone, M. L.
AU - Pismataro, R.
AU - D'Eril, G. V.
AU - Barassi, A.
AU - Pacciolla, R.
AU - Faraci, G.
AU - Torresani, S.
AU - Rosmini, B.
AU - Carpi, F.
AU - Soelva, M.
AU - Anderlan, M.
AU - De Francesco, M.
AU - Duregger, E.
AU - Torresani, S.
AU - Vettori, C.
AU - Doimo, S.
AU - Kompatscher, E.
AU - Soelva, M.
AU - Torresani, S.
AU - Forer, M.
AU - Kerschbaumer, H.
AU - Gampe, A.
AU - Nicoletti, M.
AU - Acerbi, C.
AU - Aquilino, D.
AU - Azzali, S.
AU - Bensi, L.
AU - Bissoli, S.
AU - Cappellari, D.
AU - Casana, E.
AU - Campagnola, N.
AU - Dal Corso, E.
AU - Di Micco, E.
AU - Gobbi, E.
AU - Ferri, L.
AU - Gobbi, E.
AU - Mairaghi, L.
AU - Malak, S.
AU - Mesiano, L.
AU - Paterlini, F.
AU - Perini, M.
AU - Puliti, E. M.
AU - Rispoli, R.
AU - Rizzo, E.
AU - Sergenti, C.
AU - Soave, M.
AU - Alpi, A.
AU - Bislenghi, L.
AU - Bolis, T.
AU - Colnaghi, F.
AU - Fascendini, S.
AU - Grignani, S.
AU - Meneghelli, A.
AU - Patelli, G.
AU - Faravelli, C.
AU - Casale, S.
AU - Zimmermann, C.
AU - Deledda, G.
AU - Goss, C.
AU - Mazzi, M.
AU - Rimondini, M.
AU - Gennarelli, M.
AU - Scassellati, C.
AU - Bonvicini, C.
AU - Longo, S.
AU - Bocchio Chiavetto, L.
AU - Zanardini, R.
AU - Ventriglia, M.
AU - Squitti, R.
AU - Frisoni, G.
AU - Pievani, M.
AU - Balestrieri, M.
AU - Brambilla, P.
AU - Perlini, C.
AU - Marinelli, V.
AU - Bellani, M.
AU - Rambaldelli, G.
AU - Bertoldo, A.
AU - Atzori, M.
AU - Mazzi, F.
AU - Carpeggiani, P.
AU - Beltramello, A.
AU - Alessandrini, F.
AU - Pizzini, F.
AU - Zoccatelli, G.
AU - Sberna, M.
AU - Konze, A.
AU - Politi, P.
AU - Emanuele, E.
AU - Brondino, N.
AU - Martino, G.
AU - Bergami, A.
AU - Zarbo, R.
AU - Riva, M. A.
AU - Fumagalli, F.
AU - Molteni, R.
AU - Calabrese, F.
AU - Guidotti, G.
AU - Luoni, A.
AU - Macchi, F.
AU - Artioli, S.
AU - Baldetti, M.
AU - Bizzocchi, M.
AU - Bolzon, D.
AU - Bonello, E.
AU - Cacciari, G.
AU - Carraresi, C.
AU - Cascio, M. T.
AU - Caselli, G.
AU - Furlato, K.
AU - Garlassi, S.
AU - Gavarini, A.
AU - Lunardi, S.
AU - Macchetti, F.
AU - Marteddu, V.
AU - Plebiscita, G.
AU - Poli, S.
AU - Totaro, S.
AU - Bebbington, P.
AU - Birchwood, M.
AU - Dazzan, P.
AU - Kuipers, E.
AU - Thornicroft, G.
AU - Pariante, C.
AU - Lawrie, S.
AU - Pariante, C.
AU - Soares, J. C.
PY - 2012/5/30
Y1 - 2012/5/30
N2 - 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 enrolment 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.Trial registration: ClinicalTrials.gov Identifier NCT01436331.
AB - 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 enrolment 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.Trial registration: ClinicalTrials.gov Identifier NCT01436331.
KW - Family intervention
KW - First-episode psychosisEarly psychosisCognitive behavioral therapyPsychosocial interventionAssertive community treatment
UR - http://www.scopus.com/inward/record.url?scp=84861553383&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84861553383&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-13-73
DO - 10.1186/1745-6215-13-73
M3 - Article
C2 - 22647399
AN - SCOPUS:84861553383
VL - 13
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 1745
ER -