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.
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
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.
Section of Psychiatry, Department of Public Health and Community Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy. mirella.ruggeri@univr.it
Mirella
M
Ruggeri
Chiara
C
Bonetto
Antonio
A
Lasalvia
Giovanni
G
De Girolamo
Angelo
A
Fioritti
Paola
P
Rucci
Paolo
P
Santonastaso
Giovanni
G
Neri
Francesca
F
Pileggi
Daniela
D
Ghigi
Maurizio
M
Miceli
Silvio
S
Scarone
Angelo
A
Cocchi
Stefano
S
Torresani
Carlo
C
Faravelli
Christa
C
Zimmermann
Anna
A
Meneghelli
Carla
C
Cremonese
Paolo
P
Scocco
Emanuela
E
Leuci
Fausto
F
Mazzi
Massimo
M
Gennarelli
Paolo
P
Brambilla
Sarah
S
Bissoli
Maria Elena
ME
Bertani
Sarah
S
Tosato
Katia
K
De Santi
Sara
S
Poli
Doriana
D
Cristofalo
Michele
M
Tansella
Mirella
M
Ruggeri
Maria Elena
ME
Mirella
Sarah
S
Bissoli
Chiara
C
Bonetto
Doriana
D
Cristofalo
Katia
K
De Santi
Antonio
A
Lasalvia
Silvia
S
Lunardi
Valentina
V
Negretto
Sara
S
Poli
Sarah
S
Tosato
Maria Grazia
MG
Zamboni
Mario
M
Ballarin
Giovanni
G
De Girolamo
Angelo
A
Fioritti
Giovanni
G
Neri
Francesca
F
Pileggi
Paola
P
Rucci
Luisella
L
Bocchio Chiavetto
Catia
C
Scasselatti
Roberta
R
Zanardini
Paolo
P
Brambilla
Marcella
M
Bellani
Alessandra
A
Bertoldo
Veronica
V
Marinelli
Valentina
V
Negretto
Cinzia
C
Perlini
Gianluca
G
Rambaldelli
Antonio
A
Lasalvia
Mariaelena
M
Bertani
Sarah
S
Bissoli
Lorenza
L
Lazzarotto
Sonia
S
Bardella
Francesco
F
Gardellin
Dario
D
Lamonaca
Antonio
A
Lasalvia
Marco
M
Lunardon
Renato
R
Magnabosco
Marilena
M
Martucci
Stylianos
S
Nicolau
Francesco
F
Nifosì
Michele
M
Pavanati
Massimo
M
Rossi
Carlo
C
Piazza
Gabriella
G
Piccione
Alessandra
A
Sala
Annalisa
A
Sale
Benedetta
B
Stefan
Spyridon
S
Zotos
Mirko
M
Balbo
Ileana
I
Boggian
Enrico
E
Ceccato
Rosa
R
Dall'Agnola
Francesco
F
Gardellin
Barbara
B
Girotto
Claudia
C
Goss
Dario
D
Lamonaca
Antonio
A
Lasalvia
Roberta
R
Leoni
Alessia
A
Mai
Annalisa
A
Pasqualini
Michele
M
Pavanati
Carlo
C
Piazza
Gabriella
G
Piccione
Stefano
S
Roccato
Alberto
A
Rossi
Annalisa
A
Sale
Stefania
S
Strizzolo
Spyridon
S
Zotos
Anna
A
Urbani
Flavia
F
Ald
Barbara
B
Bianchi
Paola
P
Cappellari
Raffaello
R
Conti
Laura
L
De Battisti
Ermanna
E
Lazzarin
Silvia
S
Merlin
Giuseppe
G
Migliorini
Tecla
T
Pozzan
Lucio
L
Sarto
Stefania
S
Visonà
Andrea
A
Brazzoli
Antonella
A
Campi
Roberta
R
Carmagnani
Sabrina
S
Giambelli
Annalisa
A
Gianella
Lino
L
Lunardi
Davide
D
Madaghiele
Paola
P
Maestrelli
Lidia
L
Paiola
Elisa
E
Posteri
Loretta
L
Viola
Valentina
V
Zamberlan
Marta
M
Zenari
Sarah
S
Tosato
Martina
M
Zanoni
Giovanni
G
Bonadonna
Mariacristina
M
Bonomo
Paolo
P
Santonastaso
Carla
C
Cremonese
Paolo
P
Scocco
Angela
A
Veronese
Patrizia
P
Anderle
Andrea
A
Angelozz
Isabelle
I
Amalric
Gabriella
G
Baron
Enrico Bruttomesso Fabio
EB
Candeago
Franco
F
Castelli
Maria
M
Chieco
Carla
C
Cremonese
Enrico
E
Di Costanzo
Mario
M
Derossi
Michele
M
Doriguzzi
Osvaldo
O
Galvano
Marcello
M
Lattanz
Roberto
R
Lezzi
Marisa
M
Marcato
Alessandro
A
Marcolin
Franco
F
Marini
Manlio
M
Matranga
Donato
D
Scalabrin
Maria
M
Zucchetto
Flavio
F
Zadro
Giovanni
G
Austoni
Maria
M
Bianco
Francesca
F
Bordino
Filippo
F
Dario
Alessandro
A
De Risio
Aldo
A
Gatto
Simona
S
Granà
Emanuele
E
Favero
Anna
A
Franceschin
Silvia
S
Friederici
Vanna
V
Marangon
Michela
M
Pascolo
Luana
L
Ramon
Paolo
P
Scocco
Angela
A
Veronese
Stefania
S
Zambolin
Rossana
R
Riolo
Antonella
A
Buffon
Carla
C
Cremonese
Elena
E
Di Bortolo
Silvia
S
Friederici
Stefania
S
Fortin
Marisa
M
Marcato
Francesco
F
Matarrese
Simona
S
Mogni
Novella
N
Codemo
Alessio
A
Russi
Alessandra
A
Silvestro
Elena
E
Turella
Paola
P
Viel
Anna
A
Dominoni
Lorenzo
L
Andreose
Mario
M
Boemio
Loretta
L
Bressan
Arianna
A
Cabbia
Elisabetta
E
Canesso
Romina
R
Cian
Claudia
C
Dal Piccol
Maria Manuela
MM
Dalla Pasqua
Anna
A
Di Prisco
Lorena
L
Mantellato
Monica
M
Luison
Sandra
S
Morgante
Mirna
M
Santi
Moreno
M
Sacillotto
Mauro
M
Scabbio
Patrizia
P
Sponga
M Luisa
ML
Sguotto
Flavia
F
Stach
M Grazia
MG
Vettorato
Giorgio
G
Martinello
Francesca
F
Dassiè
Stefano
S
Marino
Linda
L
Cibiniel
Ilenia
I
Masetto
Marisa
M
Marcato
Oscar
O
Cabianca
Amalia
A
Valente
Livio
L
Caberlotto
Alberto
A
Passoni
Patrizia
P
Flumian
Luigino
L
Daniel
Massimo
M
Gion
Stanziale
S
Stanziale
Flora
F
Alborino
Vladimiro
V
Bortolozzo
Lucio
L
Bacelle
Leonarda
L
Bicciato
Daniela
D
Basso
Filippo
F
Navaglia
Fabio
F
Manoni
Mauro
M
Ercolin
Giovanni
G
Neri
Franco
F
Giubilini
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M
Imbesi
Emanuela
E
Leuci
Fausto
F
Mazzi
Enrico
E
Semrov
Castel S
CS
Giovanni
Valli
V
Taro e Ceno
Polo
P
Ovest
Silvio
S
Anelli
Mario
M
Amore
Laura
L
Bigi
Welsch
W
Britta
Giovanna Barazzoni
GB
Anna
Uobes
U
Bonatti
Maria
M
Borziani
Isabella
I
Crosato
Raffaele
R
Galluccio
Margherita
M
Galeotti
Mauro
M
Gozzi
Vanna
V
Greco
Emanuele
E
Guagnini
Stefania
S
Pagani
Malvasi
M
Maccherozzi
Francesco
F
Marchi
Ermanno
E
Melato
Elena
E
Mazzucchi
Franco
F
Marzullo
Pietro
P
Pellegrini
Nicoletta
N
Petrolini
Paolo
P
Volta
Silvio
S
Anelli
Franca
F
Bonara
Elisabetta
E
Brusamonti
Roberto
R
Croci
Ivana
I
Flamia
Francesca
F
Fontana
Romina
R
Losi
Fausto
F
Mazzi
Roberto
R
Marchioro
Stefania
S
Pagani
Luigi
L
Raffaini
Luca
L
Ruju
Antonio
A
Saginario
M Grazia
MG
Tondelli
Donatella
D
Marrama
Lucia
L
Bernardelli
Federica
F
Bonacini
Annaluisa
A
Florindo
Marina
M
Merli
Patrizia
P
Nappo
Lorena
L
Sola
Ornella
O
Tondelli
Matteo
M
Tonna
M Teresa
MT
Torre
Morena
M
Tosatti
Gloria
G
Venturelli
Daria
D
Zampolla
Antonia
A
Bernardi
Cinzia
C
Cavalli
Lorena
L
Cigala
Cinzia
C
Ciraudo
Antonia
A
Di Bari
Lorena
L
Ferri
Fabiana
F
Gombi
Sonia
S
Leurini
Elena
E
Mandatelli
Stefano
S
Maccaferri
Mara
M
Oroboncoide
Barbara
B
Pisa
Cristina
C
Ricci
Enrica
E
Poggi
Corrado
C
Zurlini
Monica
M
Malpeli
Rossana
R
Colla
Elvira
E
Teodori
Luigi
L
Vecchia
Rocco
R
D'Andrea
Tommaso
T
Trenti
Paola
P
Paolini
Fausto
F
Mazzi
Paolo
P
Carpeggiani
Francesca
F
Pileggi
Daniela
D
Ghigi
Mariateresa
M
Gagliostro
Michela
M
Pratelli
Paola
P
Rucci
S
S
Lazzaro
Antonio
A
Antonelli
Luana
L
Battistini
Francesca
F
Bellini
Eva
E
Bonini
Caterina Bruschi Rossella
CB
Capelli
Cinzia
C
DiDomizio
Chiara
C
Drei
Giuseppe
G
Fucci
Alessandra
A
Gualandi
Maria Rosaria
MR
Grazia
Anna M
AM
Losi
Federica Mazzanti Paola
FM
Mazzoni
Daniela
D
Marangoni
Giuseppe
G
Monna
Marco
M
Morselli
Alessandro
A
Oggioni
Silvio
S
Oprandi
Walter
W
Paganelli
Morena
M
Passerini
Maria
M
Piscitelli
Gregorio
G
Reggiani
Gabriella
G
Rossi
Federica
F
Salvatori
Simona
S
Trasforini
Carlo
C
Uslenghi
Simona
S
Veggetti
Giovanna
G
Bartolucci
Rosita
R
Baruffa
Francesca
F
Bellini
Raffaella
R
Bertelli
Lidia
L
Borghi
Patrizia
P
Ciavarella
Cinzia
C
DiDomizio
Giuseppe
G
Monna
Alessandro
A
Oggioni
Elisabetta
E
Paltrinieri
Francesco
F
Rizzardi
Piera
P
Serra
Damiano
D
Suzzi
Uslenghi
U
Carlo
Maria
M
Piscitelli
Paolo
P
Arienti
Fabio
F
Aureli
Rosita
R
Avanzi
Vincenzo
V
Callegari
Alessandra
A
Corsino
Paolo
P
Host
Rossella
R
Michetti
Michela
M
Pratelli
Francesco
F
Rizzo
Paola
P
Simoncelli
Elena
E
Soldati
Eraldo
E
Succi
Massimo
M
Bertozzi
Elisa
E
Canetti
Luca
L
Cavicchioli
Elisa
E
Ceccarelli
Stefano
S
Cenni
Glenda
G
Marzola
Vanessa
V
Gallina
Carla
C
Leoni
Andrea
A
Olivieri
Elena
E
Piccolo
Sabrina
S
Ravagli
Rosaria
R
Russo
Daniele
D
Tedeschini
Marina
M
Verenini
Walter
W
Abram
Veronica
V
Granata
Alessandro
A
Curcio
Giovanni
G
Guerra
Samuela
S
Granini
Lara
L
Natali
Enrica
E
Montanari
Fulvia
F
Pasi
Umbertina
U
Ventura
Stefania
S
Valenti
Masi
M
Francesca
Rossano
R
Farneti
Paolo
P
Ravagli
Romina
R
Floris
Otello
O
Maroncelli
Gianbattista
G
Volpones
Donatella
D
Casali
Maurizio
M
Miceli
Andrea
A
Bencini
Massimo
M
Cellini
Luca
L
De Biase
Leonardo
L
Barbara
Liedl
L
Charles
Cristina
C
Pratesi
Andrea
A
Tanini
Massimo
M
Cellini
Maurizio
M
Miceli
Riccardo
R
Loparrino
Cristina
C
Pratesi
Cinzia
C
Ulivelli
Cristina
C
Cussoto
Nico
N
Dei
Enrico
E
Fumanti
Manuela
M
Pantani
Gregorio
G
Zeloni
Rossella
R
Bellini
Roberta
R
Cellesi
Nadia
N
Dorigo
Patrizia
P
Gullì
Luisa
L
Ialeggio
Maria
M
Pisanu
Graziella
G
Rinaldi
Angela
A
Konze
Angelo
A
Cocchi
Anna
A
Meneghelli
Mario
M
Bianco
Litta
L
Modignani
Maria
M
Frova
Emiliano
E
Monzani
Alberto
A
Zanobio
Marina
M
Malagoli
Roberto
R
Pagani
Simona
S
Barbera
Carla
C
Morganti
Emiliano
E
Monzani
Elisabetta Sarzi
ES
Amadè
Virginia
V
Brambilla
Anita
A
Montanari
Giori
G
Caterina
Carmelo
C
Lopez
Alessandro
A
Marocchi
Andrea
A
Moletta
Maurizio
M
Sberna
M Teresa
MT
Cascio
Silvio
S
Scarone
Maria Laura
ML
Manzone
Barbera
B
Barbara
Luisa
L
Mari
Maria L
ML
Manzone
Edoardo
E
Razzini
Yvonne
Y
Bianchi
M Rosa
MR
Pellizzer
Antonella
A
Verdecchia
M Gabriella
MG
Sferrazza
M Laura
ML
Manzone
Rosa
R
Pismataro
Gian Vico Melzi
GV
D'Eril
Alessandra
A
Barassi
Rosana
R
Pacciolla
Gloria
G
Faraci
Stefano
S
Torresani
Bolzano
B
Rosmini
Fabio
F
Carpi
Margit
M
Soelva
Monica
M
Anderlan
Michele
M
De Francesco
Efi
E
Duregger
Stefano
S
Torresani
Carla
C
Vettori
Sabrina
S
Doimo
Erika
E
Kompatscher
Margit
M
Soelva
Stefano
S
Torresani
Michael
M
Forer
Helene
H
Kerschbaumer
Anna
A
Gampe
Maira
M
Nicoletti
Chiara
C
Acerbi
Daniele
D
Aquilino
Silvia
S
Azzali
Luca
L
Bensi
Sarah
S
Bissoli
Davide
D
Cappellari
Elisa
E
Casana
Nadia
N
Campagnola
Elisa
E
Dal Corso
Elisabetta
E
Di Micco
Erika
E
Gobbi
Laura
L
Ferri
Erika
E
Gobbi
Laura
L
Mairaghi
Sara
S
Malak
Luca
L
Mesiano
Federica
F
Paterlini
Michela
M
Perini
Elena Maria
EM
Puliti
Rosaria
R
Rispoli
Elisabetta
E
Rizzo
Chiara
C
Sergenti
Manuela
M
Soave
Andrea
A
Alpi
Laura
L
Bislenghi
Tiziana
T
Bolis
Francesca
F
Colnaghi
Simona
S
Fascendini
Silvia
S
Grignani
Anna
A
Meneghelli
Giovanni
G
Patelli
Carlo
C
Faravelli
Silvia
S
Casale
Christa
C
Zimmermann
Giuseppe
G
Deledda
Claudia
C
Goss
Mariangela
M
Mazzi
Michela
M
Rimondini
Massimo
M
Gennarelli
Catia
C
Scassellati
Cristian
C
Bonvicini
Sara
S
Longo
Luisella
L
Bocchio Chiavetto
Roberta
R
Zanardini
Mariacarla
M
Ventriglia
Rosanna
R
Squitti
Giovanni
G
Frisoni
Michela
M
Pievani
Matteo
M
Balestrieri
Paolo
P
Brambilla
Cinzia
C
Perlini
Veronica
V
Marinelli
Marcella
M
Bellani
Gianluca
G
Rambaldelli
Alessandra
A
Bertoldo
Manfredo
M
Atzori
Fausto
F
Mazzi
Paolo
P
Carpeggiani
Alberto
A
Beltramello
Franco
F
Alessandrini
Francesca
F
Pizzini
Giada
G
Zoccatelli
Maurizio
M
Sberna
Angela
A
Konze
Pierluigi
P
Politi
Enzo
E
Emanuele
Natascia
N
Brondino
Gianvito
G
Martino
Alessandra
A
Bergami
Roberto
R
Zarbo
Marco Andrea
MA
Riva
Fabio
F
Fumagalli
Raffaella
R
Molteni
Francesca
F
Calabrese
Gianluigi
G
Guidotti
Alessia
A
Luoni
Flavia
F
Macchi
Stefania
S
Artioli
Marco
M
Baldetti
Milena
M
Bizzocchi
Donatella
D
Bolzon
Elisa
E
Bonello
Giorgia
G
Cacciari
Claudia
C
Carraresi
M Teresa
MT
Cascio
Gabriele
G
Caselli
Karin
K
Furlato
Sara
S
Garlassi
Alessandro
A
Gavarini
Silvia
S
Lunardi
Fabio
F
Macchetti
Valentina
V
Marteddu
Giorgia
G
Plebiscita
Sara
S
Poli
Stefano
S
Totaro
Paul
P
Bebbington
Max
M
Birchwood
Paola
P
Dazzan
Elisabeth
E
Kuipers
Graham
G
Thornicroft
Carmine
C
Pariante
Steve
S
Lawrie
Carmine
C
Pariante
Jair C
JC
Soares
D019090:Case Management; D016000:Cluster Analysis; D015928:Cognitive Behavioral Therapy; D003155:Community Mental Health Centers; D003156:Community Mental Health Services; D005195:Family Relations; D006801:Humans; D007558:Italy; D018579:Patient Selection; D011618:Psychotic Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D012008:Recurrence; D012107:Research Design; D018401:Sample Size; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome