A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis

NCT01436331 | Completed

• 2 other identifiers: 1682C.U.P. H 61J08000200001
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly been conducted on non epidemiologically representative samples in experimental settings, raising the risk thereby of underestimating the complexities involved in treating onset psychosis in "real world" services. The PIANO Trial (Psychosis early Intervention and Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics, Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at 9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their family members recruited from a 10 million inhabitant catchment area; 2) identify barriers that may hinder its feasibility and patient/family conditions that can render this type of treatment ineffective or inappropriate; 3) identify clinical, psychological, and environmental and service predictors of treatment effectiveness in FEP. Study participants will be recruited from Community Mental Health Centers (CMHCs) operating for the Italian National Health Service and located in several Northern and Central Regions of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which is considered the gold standard approach for trials that evaluate complex interventions implemented at the institutional level, with the aim of improving health. The assignment units (clusters) are the CMHCs, and the units of observation and analysis are the Centers' patients and their family members. Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to serve as the patient's referent. Patient enrollment will take place over a 1 year interval, after a 3 month-long piloting. The fidelity of the experimental interventions and the characteristics of TAU will be regularly monitored. Several psychopathological, psychological, functioning and service use variables will be assessed at baseline and 9 month follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per year for functional psychoses (as previously estimated in Italy), the investigators expect to recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the size of the trial would detect at 9 months a difference in terms of primary outcome from 25% for the TAU arm to 10% for the intervention arm, with a power of 80%.

Conditions

Psychosis

Keywords

First episode psychosis; Early Psychosis; Cognitive Behavioural therapy; Psychosocial Intervention; Assertive Community treatment; Family Intervention; Mental Disorders; Psychotic Disorders; Schizophrenia and Disorders with Psychotic Features; Affective Disorders, Psychotic

Outcome Measures

Primary Outcomes (2)

• Relapses

  We define relapse as an episode that has resulted in an admission to a psychiatric inpatient unit (number and days of hospitalization) and/or any case noted record of increase in psychotic symptoms' severity during the study period

  9 months

• Positive and negative symptoms

  Positive and Negative symptoms will be measured by the positive and negative subscales of the PANSS and by the PSYRATS

  change from baseline at 9 month follow-up

Secondary Outcomes (7)

• Service Satisfaction in patients and relatives

  9 months

• Patient Functioning

  change from baseline at 9 month follow-up

• Patient emotional wellbeing

  change from baseline at 9 month follow-up

• Service disengagement

  9 months

• Patient Needs for care

  change from baseline at 9 month follow-up

Study Arms (2)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Other: Treatment As Usual (TAU)

TAU+CBT for pts+Family Intervention+CM

EXPERIMENTAL

Behavioral: TAU+CBT for pts+Family Intervention+CM.

Interventions

Treatment As Usual (TAU) OTHER

Services participating in the trial are routine public Community Mental Health Centres (CMHCs), which operate within the Italian National Health Service. Multi-disciplinary teams operating these CMHCs provide a wide range of integrated programmes, including inpatient care, day care, rehabilitation, outpatient care, home visits, 24-hour emergency services, and residential facilities. Standard care for FEP patients generally consists of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management at the CMHC level. Family interventions generally consist of non-specific informal support/educational sessions. Both specialized individual psychotherapeutic interventions for patients (included CBT) and specialized psycho-educational or cognitive-oriented family interventions are usually not provided, due to lack of trained professionals.

Also known as: standard treatment, control treatment

Treatment As Usual (TAU)

TAU+CBT for pts+Family Intervention+CM. BEHAVIORAL

The experimental treatment package is administered by the CMHC staff, after training and with ongoing supervision by experts. Cognitive-behavioural therapy (CBT) is based on the model developed by Kuipers in 1998 and Garety in 2008. A total of 20-30 CBT sessions per patient will be delivered, with weekly sessions during months 1-3 and fortnightly over the following 6 months. Family Intervention is based on the model proposed by Leff in 1982 and further developed by Kuipers in 2002. It includes a total of 10-15 sessions with each individual family: 6 in months 1-3, and at least 1 session/month in the 6 months afterwards. Every patient/family will have a dedicated Case Manager, who will coordinate all planned interventions. Specific training programs have been developed, with assessment of the staff competence. Detailed Manuals based on international standards have been developed and will be used. Fidelity will be measured at the end of the trial.

Also known as: Multi-element intervention, Family psychoeducation

TAU+CBT for pts+Family Intervention+CM

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-54 yrs
• residence in the catchment area of participating Community Mental Health Centres
• presence of (a) at least 1 of the following symptoms: hallucinations, delusions, qualitative speech disorder, qualitative psychomotor disorder, bizarre or grossly inappropriate behavior, or (b) at least 2 of the following symptoms: loss of interest, initiative and drive, social withdrawal, episodic severe excitement, purposeless destructiveness, overwhelming fear, marked self-neglect
• first lifetime contact with participating CMHC, occasioned by symptoms enumerated in 3.
• clinical ICD-10 diagnosis of F20-29; F30.2, F31.2, F31.5, F31.6, F32.3, F33.3, F1x.4; F1x.5; F1x.7;F20-F29, as confirmed after 6 months by using the Schedule for Clinical Assessment in Neuropsychiatry (WHO SCAN)

You may not qualify if:

• prior anti-psychotic medication (\> 3 months) provided by any psychiatric or other medical agencies
• mental disorders due to a general medical condition

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona - Section of Psychiatry and Clinical Psychology, Department of Public Health and Community Medicine

Verona, 37134, Italy

Location

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• 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, Ruggeri M; GET UP Group. 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. Br J Psychiatry. 2017 May;210(5):342-349. doi: 10.1192/bjp.bp.116.190058. Epub 2017 Mar 16.

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• Ruggeri M, Bonetto C, Lasalvia A, De Girolamo G, Fioritti A, 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 M, Brambilla P, Bissoli S, Bertani ME, Tosato S, De Santi K, Poli S, Cristofalo D, Tansella M; GET UP GROUP; Ruggeri M, Mirella ME, Bissoli S, Bonetto C, Cristofalo D, De Santi K, Lasalvia A, Lunardi S, Negretto V, Poli S, Tosato S, Zamboni MG, Ballarin M, De Girolamo G, Fioritti A, Neri G, Pileggi F, Rucci P, Bocchio Chiavetto L, Scasselatti C, Zanardini R, Brambilla P, Bellani M, Bertoldo A, Marinelli V, Negretto V, Perlini C, Rambaldelli G, Lasalvia A, Bertani M, Bissoli S, Lazzarotto L, Bardella S, Gardellin F, Lamonaca D, Lasalvia A, Lunardon M, Magnabosco R, Martucci M, Nicolau S, Nifosi 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, Gardellin F, 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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 MM, Di Prisco A, Mantellato L, Luison M, Morgante S, Santi M, Sacillotto M, Scabbio M, Sponga P, Sguotto ML, Stach F, Vettorato MG, Martinello G, Dassie 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 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, 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 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, 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 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, 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, Gulli 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, Amade ES, Brambilla V, Montanari A, Caterina G, Lopez C, Marocchi A, Moletta A, Sberna M, Cascio MT, Scarone S, Manzone ML, Barbara B, Mari L, Manzone ML, Razzini E, Bianchi Y, Pellizzer MR, Verdecchia A, Sferrazza MG, Manzone ML, Pismataro R, D'Eril GV, 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 EM, 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 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, Cascio MT, 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 JC. 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. Trials. 2012 May 30;13:73. doi: 10.1186/1745-6215-13-73.

  PMID: 22647399 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic

Interventions

Therapeutics

Study Officials

• Mirella RUGGERI, M.D.

  Universita' di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 19, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

IT (1)