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

Abstract

BackgroundMulti-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/DesignThe 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 registrationClinicalTrials.gov Identifier NCT01436331

The “Reggio Emilia At‐Risk Mental States” program: A diffused, “liquid” model of early intervention in psychosis implemented in an Italian Department of Mental Health

“…In September 2012, after being involved in the GET-UP trial (that was a study protocol aimed to evaluate the 9-month effectiveness and the feasibility in real-world routine clinical settings of an EIPbased multicomponent psychosocial intervention compared with Treatment As Usual [TAU] in a large cohort of FEP patients recruited from a 10 million inhabitant catchment area) (Ruggeri et al, 2012), the General Direction of the Emilia-Romagna Health Care Service financed a regional project (the "Progetto Regionale Esordi Psicotici"…”

“…In September 2012, after being involved in the GET‐UP trial (that was a study protocol aimed to evaluate the 9‐month effectiveness and the feasibility in real‐world routine clinical settings of an EIP‐based multicomponent psychosocial intervention compared with Treatment As Usual [TAU] in a large cohort of FEP patients recruited from a 10 million inhabitant catchment area) (Ruggeri et al, ), the General Direction of the Emilia‐Romagna Health Care Service financed a regional project (the “Progetto Regionale Esordi Psicotici” [PREP]) with the aim of implementing innovative protocols of intervention based on the EIP model within all the Emilia Romagna Departments of Mental Health (Raballo et al, ). Specifically, main objectives of this project were: (a) to train the professional staff of each regional department of mental health on the theoretical and operational cores of the EIP model, and (b) to established a specialized EIP program within all departments, aimed to the assessment, diagnosis and treatment of FEP patients according to well‐defined, state‐of‐art guidelines on the topic (Regione Emilia Romagna, ).…”

Fidelity scales and performance measures to support implementation and quality assurance for first episode psychosis services

“…Such programs have been widely implemented over the last 20 years (McGorry, Edwards, Mihalopoulos, Harrigan, & Jackson, ). Several large randomized controlled studies of programs in different health care systems have demonstrated improved outcomes across several domains compared with treatment as usual (Kane et al, ; Petersen, Jeppesen et al, ; Ruggeri et al, ). The programs that have been tested in randomized controlled studies have a number of common components which have been identified through a process of systematic review and consensus (Addington, Mckenzie, Norman, Wang, & Bond, ).…”

Dimensional structure of first episode psychosis

“…Based on this assumption, clinical syndromes may be viewed as the result of multiple interactions between different and quite distinct psychopathological dimensions (Keshavan, Tandon, Boutros, & Nasrallah, 2008;Tandon, Nasrallah, & Keshavan, 2009 (Eaton, Thara, Federman, Melton, & Liang, 1995;Marchesi et al, 2015). Likewise, institutionalization, long-term neuroleptic therapy, illness duration and ageing may contribute to shape both clinical presentation and outcome (McGorry et al, 1998;Ruggeri et al, 2012;Marchesi et al, 2015). As the early stages of psychosis are not affected by long-term confounding factors (Langeveld et al, 2013), first episode psychotic patients may represent a particularly useful study population where to better explore clinical expression of the core symptoms of psychoses.…”