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.

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.

[Heterogeneity of the Departments of Mental Health in the Veneto Region ten years after the National Plan 1994-96 for Mental Health. Which implication for clinical practice? Findings from the PICOS Project].

Aims: This study aims to present data on structural and human resources of public mental health services located in the Veneto Region, Italy, and to discuss them in the light of implementation of the first National Target Plan for Mental Health ("Progetto Obiettivo 1994-1996") ten years after its launch.

Methods: The study was conducted in the context of the PICOS (Psychosis Incident Cohort Outcome Study) Project, a large first-presentation multisite study on patients with psychotic disorders attending community mental heath services in the Veneto Region. Human and structural resources were surveyed in 26 study sites using a structured interview administered by the PICOS local referents.