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.

Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia.

Background: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study.

[Residential facilities and day centres in mental health. Is there any difference?].

Aims: We wanted to investigate to what extent and in what characteristics the patients cared in the psychiatric residential facilities (RF) were similar to those in the day-centres (DC), and whether 6-month improvements in the two settings were comparable.

Methods: We described 141 patients admitted to the RF and 180 in DC of three mental health service networks in Milan and near Milan. They were evaluated again after six months.

Outcome of community-based rehabilitation program for people with mental illness who are considered difficult to treat.

This observational study investigated the outcomes of a community-based rehabilitation program that was designed to enhance social functioning, social inclusion, and well-being of people with mental illness who were considered treatment failures by psychiatric professionals in Italy. Of the 144 patients who entered the program, 131 started the program and 109 completed either 12 or 18 months of treatment. Illness severity was assessed by the Health of the Nation Outcome Scales (HoNOS) and social functioning by the Social and Occupational Functioning Assessment Scale (SOFAS).