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
Highlights
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
A cluster design was chosen based on feasibility considerations, supported by the MRC Health Services and Public Health Research Board [14], which indicated that cluster randomization is the gold standard approach for trials evaluating similar complex interventions implemented at the institutional level, with the aim of improving health
Each Community Mental Health Centre (CMHC) belongs to the Department of Mental Health (DMH), which is responsible for all mental health care for a specific catchment area
Summary
It has been suggested that most clinical and psychosocial deterioration in psychosis occurs within the first 5 years of illness onset, and that this timeframe is a crucial period for initiating treatment [1]. Literature on psychosocial interventions in FEP can be viewed in terms of two broad categories [6]: 1) studies evaluating specific (that is, single-element) psychosocial interventions (for example, individual cognitive behavioral therapy), and 2) studies evaluating comprehensive (that is, multi-element) interventions, which may include: early detection strategies; individual, group, and/or family therapy; and case management (in addition to pharmacological treatment) These interventions appear promising [7] and have been found to be associated with symptom reduction/remission, improved quality of life, increased social and cognitive functioning, low inpatient admission rates, improved insight, high degree of satisfaction with treatment, less time spent in hospital, decreased substance abuse, and fewer self-harm episodes. Efforts to implement multi-element interventions targeted to FEP in routine services should be accompanied by rigorous scientific method, with the aim of better understanding the actual effectiveness of this approach [10,11]
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