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1. Family Burden, Emotional Distress and Service Satisfaction in First Episode Psychosis. Data from the GET UP Trial

Author

Mirella Ruggeri, Antonio Lasalvia, Paolo Santonastaso, Francesca Pileggi, Emanuela Leuci, Maurizio Miceli, Silvio Scarone, Stefano Torresani, Sarah Tosato, Katia De Santi, Doriana Cristofalo, Carla Comacchio, Simona Tomassi, Carla Cremonese, Angelo Fioritti, Giovanni Patelli, Chiara Bonetto, and The GET UP Group

Subjects
early psychosis, relatives, outcomes, pragmatic trial, community psychiatry, Psychology, BF1-990
Abstract

Background: Literature has documented the role of family in the outcome of chronic schizophrenia. In the light of this, family interventions (FIs) are becoming an integral component of treatment for psychosis. The First Episode of Psychosis (FEP) is the period when most of the changes in family atmosphere are observed; unfortunately, few studies on the relatives are available.Objective: To explore burden of care and emotional distress at baseline and at 9-month follow-up and the levels of service satisfaction at follow-up in the two groups of relatives (experimental treatment EXP vs. treatment as usual TAU) recruited in the cluster-randomized controlled GET UP PIANO trial.Methods: The experimental treatment was provided by routine public Community Mental Health Centers (Italian National Health Service) and consisted of Treatment as Usual plus evidence-based additional treatment (Cognitive Behavioral Therapy for psychosis for patients, Family Intervention for psychosis, and Case Management). TAU consisted of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management and informal support/educational sessions for families. The outcomes on relatives were assessed by the Involvement Evaluation Questionnaire (IEQ-EU), the General Health Questionnaire (GHQ-12), and the Verona Service Satisfaction Scale (VSSS-EU). Differences within and between groups were evaluated.Results: At baseline, 75 TAU and 185 EXP caregivers were assessed. In the experimental group 92% of relatives participated in at least 1 family session. At follow-up both groups experienced improvement in all IEQ and GHQ items, but caregivers belonging to the EXP arm experienced a significantly greater change in 10 IEQ items (mainly pertaining to the “Tension” dimension) and in GHQ items. Due to the low sample size, a significant effectiveness was only observed for 2 IEQ items and 1 GHQ-12 item. With respect to VSSS data at follow-up, caregivers in the EXP arm experienced significantly greater satisfaction in 8 items, almost all pertaining to the dimensions “Relatives' Involvement” and “Professionals' Skills and Behavior.”Conclusions: The Family intervention for psychosis delivered in the GET UP PIANO trial reduced family burden of illness and improved emotional distress and satisfaction with services. These results should encourage to promote FIs on caregivers of first-episode psychosis patients.

Published
2017
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2. Dimensional structure of first episode psychosis

Author

Carlo Marchesi, Katia De Santi, Carla Comacchio, Emanuela Leuci, Elena Bettini, Massimo Cellini, Paola Rucci, Chiara Bonetto, Jacopo Lenzi, Antonio Lasalvia, Maurizio Miceli, Doriana Cristofalo, Paolo Santonastaso, Giovanni de Girolamo, Angelo Fioritti, Daniela Ghigi, Paolo Ossola, Laura Iozzino, Silvio Scarone, Anna Meneghelli, Matteo Tonna, Sarah Tosato, Francesca Pileggi, Angela Veronese, Stefano Torresani, Armando D'Agostino, Mirella Ruggeri, Tonna M., Ossola P., Marchesi C., Bettini E., Lasalvia A., Bonetto C., Lenzi J., Rucci P., Iozzino L., Cellini M., Comacchio C., Cristofalo D., D'Agostino A., de Girolamo G., De Santi K., Ghigi D., Leuci E., Miceli M., Meneghelli A., Pileggi F., Scarone S., Santonastaso P., Torresani S., Tosato S., Veronese A., Fioritti A., and Ruggeri M.

Subjects
Adult, Male, affective symptoms, dimension, first episode psychosis, negative symptoms, positive symptoms, Psychosis, Psychological intervention, Delusions, law.invention, Young Adult, Randomized controlled trial, Rating scale, law, medicine, Cluster Analysis, Humans, negative symptom, Biological Psychiatry, Depression (differential diagnoses), Randomized Controlled Trials as Topic, Psychiatric Status Rating Scales, Positive and Negative Syndrome Scale, Depression, business.industry, affective symptom, medicine.disease, Diagnostic and Statistical Manual of Mental Disorders, Psychiatry and Mental health, Italy, Psychotic Disorders, first episode psychosi, Female, Pshychiatric Mental Health, medicine.symptom, business, Mania, Clinical psychology, Psychopathology
Abstract

Aim Current diagnostic systems, DSM-5 and ICD-10, still adopt a categorical approach to classify psychotic disorders. The present study was aimed at investigating the structure of psychotic symptomatology in both affective and non-affective psychosis from a dimensional approach. Methods Participants with a first episode psychosis (FEP) were recruited from a cluster-randomized controlled trial (GET-UP PIANO TRIAL), offered to all Community Mental Health Centres (CMHCs) located across two northern Italian regions. After clinical stabilization, patients were assessed with a comprehensive set of psychopathological measures including the Positive and Negative Syndrome Scale, the Hamilton Depression Rating Scale and the Bech-Rafaelsen Mania Rating Scale. A two-step cluster analysis was performed. Results Overall, 257 FEP patients (male, n = 171, 66.5%; mean age = 24.96 ± 4.56) were included in the study. The cluster analysis revealed a robust four-cluster solution: delusional-persecutory (n = 82; 31.9%), depressed (n = 95; 37%), excited (n = 26; 10.1%) and negative-disorganized (n = 54; 21%), thus suggesting a quadripartite structure with both affective and non-affective dimensions. Among non-affective dimensions, negative and disorganization symptoms constituted a unique construct apart from positive symptoms. Conclusions Symptom dimensions may represent a useful tool for dissecting the indistinct and non-specific psychopathology of FEP in order to better target specific interventions.

Published
2019

3. Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants

Author

Francesca Pileggi, Daniela Ghigi, Emanuela Leuci, Paola Rucci, Katia De Santi, Paolo Scocco, Giovanni Patelli, Stefano Torresani, Carla Cremonese, Francesca Bellini, Sara Poli, Chiara Bonetto, Franco Giubilini, Giovanni Neri, Silvia Zoppei, Antonio Lasalvia, Carlo Faravelli, F Mazzi, Anna Meneghelli, Elisa Ira, Paolo Santonastaso, Angelo Fioritti, Laura Bislenghi, Silvio Scarone, Maurizio Miceli, Giovanni de Girolamo, Doriana Cristofalo, Sarah Bissoli, Mirella Ruggeri, Sarah Tosato, Michela Pratelli, Angelo Cocchi, Ruggeri, Mirella, Bonetto, Chiara, Lasalvia, Antonio, Fioritti, Angelo, De Girolamo, Giovanni, Santonastaso, Paolo, Pileggi, Francesca, Neri, Giovanni, Ghigi, Daniela, Giubilini, Franco, Miceli, Maurizio, Scarone, Silvio, Cocchi, Angelo, Torresani, Stefano, Faravelli, Carlo, Cremonese, Carla, Scocco, Paolo, Leuci, Emanuela, Mazzi, Fausto, Pratelli, Michela, Bellini, Francesca, Tosato, Sarah, De Santi, Katia, Bissoli, Sarah, Poli, Sara, Ira, Elisa, Zoppei, Silvia, Rucci, Paola, Bislenghi, Laura, Patelli, Giovanni, Cristofalo, Doriana, and Meneghelli, Anna

Subjects
Family therapy, Adult, Male, early psychosis, medicine.medical_specialty, Community Mental Health Centers, medicine.medical_treatment, Psychological intervention, family intervention, Settore M-PSI/08 - PSICOLOGIA CLINICA, Psychotic Disorder, law.invention, Follow-Up Studie, Outcome Assessment (Health Care), Randomized controlled trial, law, Outcome Assessment, Health Care, medicine, Humans, Early psychosi, Psychiatry, outcome assessment, Positive and Negative Syndrome Scale, Mental health, Community Mental Health Center, cognitive behavioral therapy, Cognitive behavioral therapy, Feasibility Studie, schizophrenia, Psychotic Disorders, Cognitive Therapy, Psychiatry and Mental Health, Cognitive therapy, Feasibility Studies, Family Therapy, Female, Psychology, Psychosocial, Case Management, Follow-Up Studies, Human
Abstract

Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services.

Published
2015

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

5. Predictors and moderators of treatment outcome in patients receiving multi-element psychosocial intervention for early psychosis: results from the GET UP pragmatic cluster randomised controlled trial.

Author

Lasalvia A, Bonetto C, Lenzi J, Rucci P, Iozzino L, Cellini M, Comacchio C, Cristofalo D, D'Agostino A, de Girolamo G, De Santi K, Ghigi D, Leuci E, Miceli M, Meneghelli A, Pileggi F, Scarone S, Santonastaso P, Torresani S, Tosato S, Veronese A, Fioritti A, and Ruggeri M

Subjects
Adolescent, Adult, Age of Onset, Cluster Analysis, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult, Cognitive Behavioral Therapy methods, Psychotic Disorders therapy
Abstract

Background The GET UP multi-element psychosocial intervention proved to be superior to treatment as usual in improving outcomes in patients with first-episode psychosis (FEP). However, to guide treatment decisions, information on which patients may benefit more from the intervention is warranted. Aims To identify patients' characteristics associated with (a) a better treatment response regardless of treatment type (non-specific predictors), and (b) a better response to the specific treatment provided (moderators). Method Some demographic and clinical variables were selected a priori as potential predictors/moderators of outcomes at 9 months. Outcomes were analysed in mixed-effects random regression models. (Trial registration: ClinicalTrials.gov, NCT01436331) Results Analyses were performed on 444 patients. Education, duration of untreated psychosis, premorbid adjustment and insight predicted outcomes regardless of treatment. Only age at first contact with the services proved to be a moderator of treatment outcome (patients aged ⩾35 years had greater improvement in psychopathology), thus suggesting that the intervention is beneficial to a broad array of patients with FEP. Conclusions Except for patients aged over 35 years, no specific subgroups benefit more from the multi-element psychosocial intervention, suggesting that this intervention should be recommended to all those with FEP seeking treatment in mental health services., Competing Interests: Declaration of interestNone., (© The Royal College of Psychiatrists 2017.)

Published
2017
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