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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruggeri, Mirella, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01436331
First received: September 14, 2011
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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%.


Condition Intervention
Psychosis
Other: Treatment As Usual (TAU)
Behavioral: TAU+CBT for pts+Family Intervention+CM.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis in a 10 Million Inhabitant Catchment Area Aimed to Measure the Treatment's Feasibility and Effectiveness: GET UP-PIANO Trial

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Relapses [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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

  • Positive and negative symptoms [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Positive and Negative symptoms will be measured by the positive and negative subscales of the PANSS and by the PSYRATS


Secondary Outcome Measures:
  • Service Satisfaction in patients and relatives [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Service satisfaction will be measured by using the Verona Service Satisfaction Scale, versions for patients and relatives

  • Patient Functioning [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Functionig will be assessed by using the Global Assessment of Functioning Scale and the WHO-Disability Assessment Scale

  • Patient emotional wellbeing [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Emotional wellbeing will be measured by using the anxiety and depression items of the PANSS and the Hamilton-D and selected items of the WHO QoL Scale

  • Service disengagement [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Service disengagement and time to service disengagement will be assessed by consulting case records and local databases

  • Patient Needs for care [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Needs for care will be assessed by using the Camberwell Assessment of Need scale

  • Key relative expressed emotions [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Expressed emotions will be measured by using the Level of Expressed Emotion Scale

  • Key relative burden [ Time Frame: change from baseline at 9 month follow-up ] [ Designated as safety issue: No ]
    Family burden will be measured by using the Involvement Evaluation Questionnaire


Enrollment: 626
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment As Usual (TAU) Other: Treatment As Usual (TAU)
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.
Other Names:
  • standard treatment
  • control treatment
Experimental: TAU+CBT for pts+Family Intervention+CM Behavioral: TAU+CBT for pts+Family Intervention+CM.
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.
Other Names:
  • Multi-element intervention
  • Family psychoeducation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-54 yrs
  2. residence in the catchment area of participating Community Mental Health Centres
  3. 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
  4. first lifetime contact with participating CMHC, occasioned by symptoms enumerated in 3.
  5. 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)

Exclusion Criteria:

  1. prior anti-psychotic medication (> 3 months) provided by any psychiatric or other medical agencies
  2. mental disorders due to a general medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436331

Locations
Italy
University of Verona - Section of Psychiatry and Clinical Psychology, Department of Public Health and Community Medicine
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Mirella RUGGERI, M.D. Universita' di Verona
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, 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, Gardellin F, Girotto B, Goss C, Lamonaca D, Lasalvia A, Leoni R, Mai A, 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 EB, 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 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, 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 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, 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 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.

Responsible Party: Ruggeri, Mirella, Professor of Psychiatry, Universita di Verona
ClinicalTrials.gov Identifier: NCT01436331     History of Changes
Other Study ID Numbers: 1682, C.U.P. H 61J08000200001
Study First Received: September 14, 2011
Last Updated: January 7, 2013
Health Authority: Italy: Ethical Committee Azienda Ospedaliera Universitaria Integrata Verona
Italy: Ministry of Health

Keywords provided by Universita di Verona:
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
First Episode Psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 16, 2014