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1. Gender and 5-years course of psychosis patients: focus on clinical and social variables

Author

Comacchio, C, Lasalvia, A, Bonetto, C, Cristofalo, D, Miglietta, E, Petterlini, S, De Santi, K, Tosato, S, Riolo, R, Cremonese, C, Ceccato, E, Zanatta, G, Ruggeri, M, Tansella, M, Bertani, M, Brambilla, P, Marrella, G, Bissoli, S, Perlini, C, Tito, P, Lunardon, M, Gava, F, Borso, E, Grandina, L, Paliotto, M, Roggia, L, Danieli, A, Poloni, C, Altiero, Mr, Piazza, F, Busana, C, Campi, A, Zanconato, A, Zamorani, P, Binotto, R, Caneva, A, Lazzarin, E, Zordan, G, Dolce, C, Fanchin, Gb, Negro, C, Gardellin, F, Crestale, M, Paiola, L, Sale, A, Morandin, I, Biondi, E, Favaretto, Acg, Geatti, S, Urbani, P, De Rossi, M, Spessotto, J, Penelope, R, Grando, L, Sgnaolin, M, Tozzini, C, Visentin, G, Schiavon, L, Gentile, B, Bolacchi, Mg, Marzotto, L, Moni, F, Rossi, L, Amalric, I, Miceli, C, De Zordo, Mr, Ramon, L, Russo, S, Rossi, R, Casagrande, G, De Nardo, V, Facchetti, A, Ramaciotti, F, Marangon, V, Coppola, G, Marcolin, A, Meneghini, P, Sbraccia, F, Segato, C, Cappellari, L, Cutugno, M, Meneghetti, L, Longhin, L, Paoleschi, B, Scalabrin, D, Antonello, L, Purgato, A, Santucci, G, Tosin, C, Volpato, R, Zurlo, R, Zucchetto, M, Pedron, M, Pinton, S, Benetazzo, M, Pavan, L, Semenzin, M, Sifari, L, Zorzi, F, Martucci, Mm, Magno, N, Meloni, G, Toniolo, E, Pavanati, M, Destro, E, Finotti, L, Fiorio, R, Marsilio, A, Pedrocco, N, Pollola, P, Lazzarotto, L, Nose, F, Rossin, P, Vivenza, V, Mazzoncini, R, Urbani, Andrea, Bianchi, L, Carcereri, G, Lunardi, L, Migliorini, G, Perdona, G, Piazza, C, Lamonaca, D, D'Agostini, G, Boggian, I, Piccione, G, Saladini, E, Gomez, F, Frazzingaro, S, Nicolaou, S, Cordioli, L, Bertolazzi, G, Pagliuca, V, Abate, M, Bortolomasi, M, Giacopuzzi, M, Segala, M, De Nardi, F, Basetto, F, Bernardis, C, Bezzetto, A, and Santi, M

Subjects
Adult, Male, Mental Health Services, First episode psychosis, Psychosis, medicine.medical_specialty, Time Factors, Adolescent, FEP, Gender, Insight, Needs, Psychopathology, Unmet needs, Cohort Studies, Young Adult, 03 medical and health sciences, Settore BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Sex Factors, 0302 clinical medicine, Female patient, medicine, Humans, Psychiatry, Depressive symptoms, Demography, Psychiatric Status Rating Scales, Health Services Needs and Demand, business.industry, Obstetrics and Gynecology, Middle Aged, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Insight into illness, Italy, Psychotic Disorders, Male patient, Female, business, Social Adjustment, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Most studies on gender and psychosis have focused on gender differences at illness onset or on the long-term outcome, whereas little is known about the impact of gender on the first years after psychosis onset. A total of 185 first episode psychosis (FEP) patients were followed for 5 years after psychosis onset, and gender differences were explored in psychopathology (PANSS), needs for care (CAN), and insight (SAI-E). Male patients showed more negative symptoms than females over time, whereas female patients showed higher levels of depressive symptoms than males throughout the study period. In addition, female patients presented more functioning unmet needs for care, but higher levels of insight into illness than males. Therapy and rehabilitative programs for FEP patients should be gender-targeted, as gender has proved to impact on psychopathology, needs for care, and insight in the very first years following psychosis onset.

Published
2019
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2. The impact of cannabis use on age of onset and clinical characteristics in first-episode psychotic patients. Data from the Psychosis Incident Cohort Outcome Study (PICOS)

Author

Tosato, Sarah, Lasalvia, Antonio, Bonetto, Chiara, Mazzoncini, Rodolfo, Cristofalo, Doriana, DE SANTI, Katia, Bertani, Mariaelena, Bissoli, Sarah Saviana, Lazzarotto, L., Marrella, Giovanna, Lamonaca, D., Riolo, R., Gardellin, F., Urbani, A., Tansella, Michele, Ruggeri, Mirella, and PICOS VENETO GROUP

Subjects
Adult, Italy/epidemiology, Male, medicine.medical_specialty, Psychosis, Marijuana Abuse, Adolescent, Poison control, Comorbidity, Cohort Studies, Young Adult, Outcome Assessment, Health Care, medicine, Humans, Cannabis, Cohort Studies, Comorbidity, Depressive Disorder/epidemiology, Depressive Disorder/psychology, Female, Humans, Incidence, Italy/epidemiology, Male, Marijuana Abuse, Psychotic Disorders, Age of Onset, Psychiatry, Biological Psychiatry, Cannabis, Psychiatric Status Rating Scales, First episode, Analysis of Variance, Depressive Disorder, biology, Incidence, Depressive Disorder/epidemiology, Middle Aged, biology.organism_classification, medicine.disease, Psychiatry and Mental health, Italy, Psychotic Disorders, Cohort, Female, Age of onset, Psychology, Depressive Disorder/psychology, Clinical psychology, Cohort study
Abstract

Cannabis use is frequent among first-episode psychosis (FEP) patients and has been associated with several clinical features. This study aimed in an FEP sample to determine whether cannabis use is associated with (1) a higher level of positive symptoms, a lower level of depression and a better premorbid adjustment, (2) an earlier age of onset, and a better premorbid IQ. The study was conducted within the framework of the Psychosis Incident Cohort Outcome Study (PICOS), a multisite collaborative research on FEP patients who attended the psychiatric services in Veneto Region, Italy. Standardized instruments were used to collect sociodemographic, clinical, and drug use data. A total of 555 FEP patients met the inclusion criteria, 517 of whom received an ICD-10 diagnosis of psychosis; 397 (55% males; mean age: 32 yrs ± 9.5) were assessed. Out of these, 311 patients agreed to be interviewed on drug and alcohol misuse; 20.3% was positive for drug misuse: cannabis (19.0%), cocaine (3.9%), and hallucinogens (3.9%). Cannabis use was not associated with a higher level of positive symptoms, but correlated with less severe depressive symptoms. No relationship was observed between premorbid adjustment or IQ and cannabis use. FEP patients who used cannabis had an earlier age of onset than abstinent patients, even after adjusting for gender and diagnosis. Our results suggest a possible causal role of cannabis in triggering psychosis in certain vulnerable subjects. Particular attention must be paid to this behaviour, because reducing cannabis use can delay or prevent some cases of psychosis.

Published
2013

3. Heterogeneity of the Departments of Mental Health in the Veneto Region ten years after the National Plan 1994-96 for Mental Health. Which implication for clinical practice? Findings from the PICOS Project

Author

Lasalvia, Antonio, Gentile, B., Ruggeri, Mirella, Marcolin, A., Nose, F., Cappellari, L., Lamonaca, D., Toniolo, E., Buana, C., Campedelli, A., Cuccato, G. C., Danieli, A., De Nardi, F, De Nardo, V., Destro, E., Favaretto, G., Frazzingaro, S., Giacopuzzi, M., Pristinger, P., Pallia, P., Rodighiero, S., Tito, P., Aprile, F., Nicolaou, S., Coppola, G., Garzotto, N., Gottardi, U., Lazzarin, E., Migliorini, G., Pavan, L., Ramaciotti, F., Roveroni, P., Russo, S., Urbani, P., Tansella, Michele, and Gruppo PICOS VENETO

Subjects
Hospitals, Psychiatric, Italy/epidemiology, medicine.medical_specialty, National Health Programs, Interprofessional Relations, Population, Psychological intervention, Context (language use), Community Mental Health Services, Hospitals Psychiatric, Catchment Area, Health, Environmental health, Health care, medicine, Humans, education, education.field_of_study, business.industry, Health Policy, Mental Disorders, Professional Practice Location, Public Health, Environmental and Occupational Health, Mental health, Psychiatry and Mental health, Italy, Family medicine, Small-Area Analysis, Cohort, Structured interview, business, Psychosocial, Public Health Administration, Day Care, Medical
Abstract

SUMMARYAims - This study aims to present data on structural and human resources of public mental health services located in the Veneto Region, Italy, and to discuss them in the light of implementation of the first National Target Plan for Mental Health (“Progetto Obiettivo 1994-1996”) ten years after its launch. Methods - The study was conducted in the context of the PICOS (Psychosis Incident Cohort Outcome Study) Project, a large first-presentation multisite study on patients with psychotic disorders attending community mental heath services in the Veneto Region. Human and structural resources were surveyed in 26 study sites using a structured interview administered by the PICOS local referents. Results - CMHCs and Day Centres were homogeneously distributed across the Region and their overall rates per resident population met the national standards; a wide variability in the distribution of Day Hospitals was found, with the overall rate per resident population very far from meeting the national standard; the overall rate for Residential Facilities beds was higher than the recommended national standard, showing however an high variability across sites. The overall rate of mental health professionals per resident population was only slightly below the national standard: this was mainly achieved thanks to non-profit organizations which supplement the public system with unspecialised professionals; however, a wide variability in the local rates per resident population was found, with the 50% of the sites showing rates far lower the national standard. Specific lack of trained professionals involved in the provision of psychosocial interventions was found in most sites. Conclusions - A marked variability in human and structural resources across community mental health services in the Veneto Region was found. Possible reasons for this heterogeneity were analysed and implications for mental health care provision were further discussed.Declaration of Interest: The study has been supported by the Regione del Veneto, Giunta Regionale, Ricerca Sanitaria Finalizzata 2004, Venezia, Italia (grant to Professor M. Ruggeri).

Published
2007

4. 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

Ruggeri, Mirella, Bonetto, Chiara, Lasalvia, Antonio, Girolamo, De, G, Fioritti, A, Rucci, P, Santonastaso, P, Neri, G, Pileggi, F, Ghigi, D, Miceli, M, Scarone, S, Cocchi, A, Torresani, S, Faravelli, C, Zimmermann, Christa, Meneghelli, A, Cremonese, C, Scocco, P, Leuci, E, Mazzi, F, Gennarelli, M, Brambilla, P, Bissoli, S, Bertani, Me, Tosato, Sarah, DE SANTI, Katia, Poli, Sara, Cristofalo, Doriana, Tansella, Michele, Get, Up, Group, Ruggeri, M, Mirella, Me, Bonetto, C, Cristofalo, D, De Santi, K, Lasalvia, A, Lunardi, S, Negretto, V, Poli, S, Tosato, S, Zamboni, Mg, Ballarin, M, Bocchio, Chiavetto, L, Scasselatti, C, Zanardini, R, Bellani, Marcella, Bertoldo, A, Marinelli, Veronica, Perlini, Cinzia, Rambaldelli, Gianluca, Bertani, M, Lazzarotto, L, Bardella, S, Gardellin, F, Lamonaca, D, 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, Girotto, B, Goss, Claudia, Leoni, R, Mai, A, Pasqualini, A, Roccato, S, Rossi, A, Strizzolo, S, Urbani, A, Ald, F, Bianchi, B, Cappellari, P, Conti, R, Battisti, De, 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, Zanoni, M, Bonadonna, G, Bonomo, M, Veronese, A, Anderle, P, Angelozz, A, Amalric, I, Baron, G, Candeago, Eb, Castelli, F, Chieco, M, Costanzo, Di, 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, Risio, De, A, Gatto, A, Granà, S, Favero, E, Franceschin, A, Friederici, S, Marangon, V, Pascolo, M, Ramon, L, Zambolin, S, Riolo, R, Buffon, A, Bortolo, Di, Fortin, S, 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, Dalla, C, Pasqua, Mm, Prisco, Di, 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, 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, Giubilini, F, Imbesi, M, 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, Bonara, F, Brusamonti, E, Croci, R, Flamia, I, Fontana, F, Losi, R, Marchioro, R, 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, Bari, Di, 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, Carpeggiani, P, Gagliostro, M, Pratelli, M, 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, Bertelli, R, Borghi, L, Ciavarella, P, Paltrinieri, E, Rizzardi, F, Serra, P, Suzzi, D, Carlo, U, Arienti, P, Aureli, F, Avanzi, R, Callegari, V, Corsino, A, Host, P, Michetti, R, 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, Bencini, A, Cellini, M, Biase, De, Barbara, L, Charles, L, Pratesi, C, Tanini, A, Loparrino, R, 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, Modignani, L, Frova, M, Monzani, E, Zanobio, A, Malagoli, M, Pagani, R, Barbera, S, Morganti, C, Amadè, Es, Brambilla, V, Montanari, A, Caterina, G, Lopez, C, Marocchi, A, Moletta, A, Sberna, M, Cascio, Mt, Manzone, Ml, Barbara, B, Mari, L, Razzini, E, Bianchi, Y, Pellizzer, Mr, Verdecchia, A, Sferrazza, Mg, Pismataro, R, D'Eril, Gv, Barassi, A, Pacciolla, R, Faraci, G, Rosmini, B, Carpi, F, Soelva, M, Anderlan, M, Francesco, De, M, Duregger, E, Vettori, C, Doimo, S, Kompatscher, E, Forer, M, Kerschbaumer, H, Gampe, A, Nicoletti, M, Acerbi, C, Aquilino, D, Azzali, S, Bensi, L, Cappellari, D, Casana, E, Campagnola, N, Dal, Corso, Di, E, Micco, E, 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, Patelli, G, Casale, S, Zimmermann, C, Deledda, G, Goss, C, Mazzi, Maria Angela, Rimondini, Michela, Scassellati, C, Bonvicini, C, Longo, S, Ventriglia, M, Squitti, R, Frisoni, G, Pievani, M, Balestrieri, M, Perlini, C, Marinelli, V, Bellani, M, Rambaldelli, G, Atzori, M, Beltramello, A, Alessandrini, F, Pizzini, Francesca, Zoccatelli, G, 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, Caselli, G, Furlato, K, Garlassi, S, Gavarini, A, Macchetti, F, Marteddu, V, Plebiscita, G, Totaro, S, Bebbington, P, Birchwood, M, Dazzan, P, Kuipers, E, Thornicroft, G, Pariante, C, Lawrie, S, Soares, J. C., Ruggeri, M., Bonetto, C., Lasalvia, A., De Girolamo, G., Bertani, M., 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, Massimo, Brambilla, P., Bissoli, S., Lazzarotto, L., Bardella, S., Gardellin, F., Lamonaca, D., Lunardon, M., Magnabosco, R., Martucci, M., Nicolau, S., Nifosì, F., Bertani, M. E., Tosato, S., De Santi, K., Poli, S., Cristofalo, D., Tansella, Michele, Lunardi, S., Negretto, V., Zamboni, M. G., Ballarin, M., Chiavetto, Luisella Bocchio, Scasselatti, C., Zanardini, R., Bellani, M., Bertoldo, A., Marinelli, Valentina, Perlini, C., Rambaldelli, G., Pasqualini, A., Pavanati, M., Rossi, M., Piazza, C., Piccione, G., Sala, A., Roccato, S., Rossi-, A., Sale, A., Stefan, B., Strizzolo, S., Zotos, S., Balbo, M., Boggian, I., Ceccato, E., Dall’Agnola, R., Girotto, B., Leoni, R., Mai, A., Urbani, Alessandro, Ald, F., Bianchi, Benedetta, 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., Zanoni, M., Bonadonna, G., Bonomo, M., Veronese, A., Anderle, P., Angelozz, A., Amalric, I., Baron, G., Candeago, E. B., Castelli, F., Chieco, M., 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, Alfredo, Gatto, A., Granà, S., Favero, E., Franceschin, A., Friederici, S., Marangon, V., Pascolo, M., Ramon, L., Zambolin, S., Riolo, R., Buffon, A., Di Bortolo, E., Fortin, S., Matarrese, F., Mogni, S., Codemo, N., Russi, A., Silvestro, Antonina, 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., DI MARINO, Simone, Cibiniel, L., Masetto, I., Cabianca, O., Valente, MADDALENA AGNESE, 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., Giubilini, F., Imbesi, M., 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, Pietro Carlo, Petrolini, N., Volta, P., Bonara, F., Brusamonti, E., Croci, R., Flamia, I., Fontana, F., Losi, R., Marchioro, R., 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, Chiara, Cigala, L., Ciraudo, C., Di Bari, A., Ferri, L., Gombi, F., Leurini, S., Mandatelli, E., Maccaferri, S., Oroboncoide, M., Pisa, B., Ricci, Carmine, Poggi, E., Zurlini, C., Malpeli, M., Colla, R., Teodori, E., Vecchia, L., D’Andrea, R., Trenti, T., Paolini, P., Carpeggiani, P., Gagliostro, M., Pratelli, M., Lazzaro, S., Antonelli, A., Battistini, Luca, Bellini, Fiorella, 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, Franco, Trasforini, S., Uslenghi, C., Veggetti, S., Bartolucci, Giuliana, Baruffa, R., Bertelli, R., Borghi, L., Ciavarella, P., Paltrinieri, E., Rizzardi, F., Serra, P., Suzzi, D., Carlo, U., Arienti, P., Aureli, F., Avanzi, R., Callegari, V., Corsino, A., Host, P., Michetti, R., 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, Elisa, Ravagli, S., Russo, R., Tedeschini, D., Verenini, M., Abram, W., Granata, V., Curcio, A., Guerra, G., Granini, S., Natali, L., Montanari, Eleonora, Pasi, F., Ventura, U., Valenti, S., Francesca, M., Farneti, R., Ravagli-, P., Floris, R., Maroncelli, O., Volpones, G., Casali, D., Bencini, A., Cellini, M., De Biase, L., Barbara, L., Charles, L., Pratesi, C., Tanini, A., Loparrino, R., 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., Modignani, L., Frova, M., Monzani, E., Amadè, E. S., Zanobio, A., Malagoli, M., Pagani-, R., Barbera, S., Morganti, C., Brambilla-, V., Montanari-, A., Caterina, G., LOPEZ CORTES, Carlo, Marocchi, A., Moletta, A., Sberna, M., Cascio, M. T., Manzone, M. L., Barbara-, B., Mari, L., Razzini, E., Bianchi-, Y., Pellizzer, M. R., Verdecchia, A., Sferrazza, M. G., Pismataro, R., D’Eril, G. V., Barassi, A., Pacciolla, R., Faraci, G., Rosmini, B., Carpi, F., Soelva, M., Anderlan, M., De Francesco, M., Duregger, E., Vettori, C., Doimo, S., Kompatscher, E., Forer, M., Kerschbaumer, H., Gampe, A., Nicoletti, M., Acerbi, C., Aquilino, D., Azzali, S., Bensi, L., Cappellari-, D., Casana, E., Campagnola, N., Dal Corso, E., Di Micco, E., Gobbi, E., Mairaghi, L., Malak, S., Mesiano, L., Paterlini, F., Perini, Matteo, Puliti, E. M., Rispoli, R., Rizzo-, E., Sergenti, C., Soave, M., Alpi, A., Bislenghi, L., Bolis, T., Colnaghi, F., Fascendini, S., Grignani, S., Patelli, G., Casale, S., Deledda, G., Goss, C., Mazzi-, M., Rimondini, M., Scassellati, C., Bonvicini, C., Longo, Salvatore, Bocchio Chiavetto, L., Ventriglia, M., Squitti, R., Frisoni, G., Pievani, M., Balestrieri, M., Atzori, M., Beltramello, A., Alessandrini, F., Pizzini, F., Zoccatelli, G., Politi, P., Emanuele, E., Brondino, N., Martino, G., Bergami, A., Zarbo, R., Riva, M. A., Fumagalli, F., Molteni, R., Calabrese, F., Guidotti, Giovanni, Luoni, Alessia, Macchi, F., Artioli, S., Baldetti, M., Bizzocchi, M., Bolzon, D., Bonello, E., Cacciari, G., Carraresi, C., Caselli, G., Furlato, K., Garlassi, S., Gavarini, A., Macchetti, F., Marteddu, V., Plebiscita, G., Totaro, S., Bebbington, P., Birchwood, M., Dazzan, P., Kuipers, E., Thornicroft, G., Pariante, C., Lawrie, S., Soares, J. C., 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, and and THE GET UP GROUP

Subjects
Research design, Time Factors, early psychosis, psychosocial interventions, cluster randomized triales, medicine.medical_treatment, Psychological intervention, Medicine (miscellaneous), Assertive community treatment, Severity of Illness Index, law.invention, Study Protocol, Randomized controlled trial, law, Recurrence, Early psychosi, Cluster Analysis, Pharmacology (medical), lcsh:R5-920, Family Relation, Community Mental Health Service, First-episode psychosis, Community Mental Health Center, Community Mental Health Services, Cognitive behavioral therapy, Treatment Outcome, Cognitive Therapy, Italy, Research Design, First-episode psychosisEarly psychosisCognitive behavioral therapyPsychosocial interventionAssertive community treatment, Family Relations, lcsh:Medicine (General), Psychosocial, Human, pragmatic trial, Early psychosis, Family intervention, Psychosocial intervention, Community Mental Health Centers, Humans, Patient Selection, Psychotic Disorders, Sample Size, Case Management, Cognitive Behavioral Therapy, medicine.medical_specialty, psychosocial interventions, Time Factor, cluster randomized triales, Psychotic Disorder, First-episode psychosi, medicine, Psychiatry, Cluster Analysi, business.industry, Mental health, Cognitive therapy, business
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

Published
2012

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