Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services.

Emotional facial expression is an important low-level mechanism contributing to the experience of empathy, thereby lying at the core of social interaction. Schizophrenia is associated with pervasive social cognitive impairments, including emotional processing of facial expressions. In this study we test a novel paradigm in order to investigate the evaluation of the emotional content of perceived emotions presented through dynamic expressive stimuli, facial mimicry evoked by the same stimuli, and their functional relation. Fifteen healthy controls and 15 patients diagnosed with schizophrenia were presented with stimuli portraying positive (laugh), negative (cry) and neutral (control) emotional stimuli in visual, auditory modalities in isolation, and congruently or incongruently associated. Participants where requested to recognize and quantitatively rate the emotional value of the perceived stimuli, while electromyographic activity of Corrugator and Zygomaticus muscles was recorded. All participants correctly judged the perceived emotional stimuli and prioritized the visual over the auditory modality in identifying the emotion when they were incongruently associated (Audio-Visual Incongruent condition). The neutral emotional stimuli did not evoke any muscle responses and were judged by all participants as emotionally neutral. Control group responded with rapid and congruent mimicry to emotional stimuli, and in Incongruent condition muscle responses were driven by what participants saw rather than by what they heard. Patient group showed a similar pattern only with respect to negative stimuli, whereas showed a lack of or a non-specific Zygomaticus response when positive stimuli were presented. Finally, we found that only patients with reduced facial mimicry (Internalizers) judged both positive and negative emotions as significantly more neutral than controls. The relevance of these findings for studying emotional deficits in schizophrenia is discussed.

Aim: From January 2013, the Parma Department of Mental Health developed a specific protocol of care (the "Parma-Early Psychosis" [Pr-EP] program) as a diffused service for early intervention in psychosis. The aims of the present research are (a) to describe the Pr-EP macroscopic organization and (b) to analyse specific process indicators across the first 5 years from its establishment. Methods: All participants were adolescent and adult help-seekers, aged 12-54 years, with a First Episode Psychosis (FEP) or at Ultra-High Risk for developing psychosis, according to well-defined diagnostic criteria. Results: At baseline, 358 individuals were offered a dedicated protocol of care and only 40 (11.8%) dropped out during the first year of intervention. In particular, an increase of referrals over time was notably found (especially in adolescence). Furthermore, Duration of Untreated Psychosis decreased over time. The baseline prevalence of FEP diagnosis was 61.4%, with schizophrenia as markedly prevalent Diagnostic and

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

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