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Abstract 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. 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 registration ClinicalTrials.gov Identifier NCT01436331

Background: Historically, it has been difficult to demonstrate an impact of training in psychological interventions for people with psychosis on routine practice and on patient outcomes. A recent pilot evaluation suggested that postgraduate training in Cognitive Behavioural Therapy for Psychosis (CBTp) increased the delivery of competent therapy in routine services. In this study, we evaluated clinical outcomes for patients receiving therapy from therapists who successfully completed training, and their association with ratings of therapist competence and therapy content. Aims: To characterize the therapy delivered during training and to inform both a calculation of effect size for its clinical impact, and the development of competence benchmarks to ensure that training standards are sufficient to deliver clinical improvement. Method: Paired patient-reported outcome measures (PROMS) were extracted from anonymized therapy case reports, and were matched with therapy ratings for each therapist. Results: Twenty clients received a course of competent therapy, including a high frequency of active therapy techniques, from nine therapists. Pre–post effect size for change in psychotic symptoms was large (d = 1.0) and for affect, medium (d = 0.6), but improved outcomes were not associated with therapist competence or therapy content. Conclusions: Therapists trained to research trial standards of competence achieved excellent clinical outcomes. Therapy effect sizes suggest that training costs may be offset by clinical benefit. Larger, methodologically stringent evaluations of training are now required. Future research should assess the necessary and sufficient training required to achieve real-world clinical effectiveness, and the cost-effectiveness of training. [ABSTRACT FROM AUTHOR]

COMT Val158Met moderates the effect of stress on psychotic symptoms. Exposure to stress is also associated with mesolimbic dopamine release in individuals experiencing low maternal care. We therefore test the hypothesis that recent stressful life events are associated with more severe positive symptoms (associated with mesolimbic dopamine release) in first-episode psychosis (FEP) patients who experienced low maternal care during childhood. We hypothesized that COMT Val158Met moderates this association. A total of 149 FEP patients recruited within the Psychosis Incident Cohort Outcome Study (PICOS) participated in the present study. Maternal care was assessed by the Parental Bonding Instrument (PBI), stressful life events were collected by the List of Events Scale and positive symptoms were assessed by the Positive and Negative Syndrome Scale (PANSS). We found that low maternal care and recent stressful life events were associated with higher level of positive symptoms at the onset (analysis of variance [ANOVA], p = 0.012), and that patients who were also homozygotes for the COMT Val158 allele had the highest level of positive symptoms (ANOVA, p = 0.024). Low maternal care and severe stressful life events may contribute to a symptomatology characterized by more severe positive symptoms at the onset, possibly due to an increased mesolimbic dopamine release. Homozygosity for the COMT Val158 allele seems to confer a biological predisposition to the stress-related hyperactivity of the mesolimbic dopaminergic system. The data imply that the mesolimbic dopaminergic system is involved in the mediation/modulation of the effect of stressful events on the vulnerability for psychosis. [ABSTRACT FROM AUTHOR]

Aims: This paper aims at presenting the most significant results emerging from the work carried out by the focus groups of the multi-centre Project SIEP-DIRECT'S. The Project is aimed at assessing the existing discrepancies between the evidence-based NICE guidelines for schizophrenia and the usual practices of care given by Italian mental health services. Each focus group was requested to give an evaluation on: (a) appropriateness of the English NICE guidelines in the context of the Italian mental health services; (b) clarity and usefulness of the 103 indicators developed on the basis of the NICE recommendations to measure their level of application within the services., Methods: In each of the 19 mental health departments or psychiatric services participating in the Project there were organized "multidisciplinary" focus groups and "specialistic" focus groups. The former included, amongst others, professional operators of the mental health services, patients, their relatives, representatives of patient organizations and general practitioners. They examined the recommendations and indicators upon which the participants could express their opinion or judgment based on their knowledge, experience or information in their possession. The latter group, composed only of psychiatrists, examined the recommendations and indicators relative to pharmacological treatments that regarded the specific competences of their professional category., Results: Most NICE recommendations seemed appropriate to the working context of the Italian services. However, some perplexity emerged as regards specific organizational models of the services, such as the specific services for psychotic onsets or the assertive outreach teams, which were believed not to be strictly pertinent to the traditional organization of mental health care in our Country. There were also some criticisms regarding the cognitive-behavioural treatments which the NICE Guidelines recommend as the principle psychotherapeutic option for patients with schizophrenia, since in many Italian services, when the use of psychological interventions are needed, the tendency is to prefer interventions based on psychodynamic theories. The SIEP indicators were generally held to be clear and acceptable., Conclusions: In the view of the focus groups, the NICE guidelines are on the whole useful and suitable for orientating the services in the choice of more efficacious practices in the treatment of patients with schizophrenia. Moreover, the results obtained legitimate the use of the set of SIEP indicators for the evaluation of good practices and the quality of care offered by Italian services. Finally, the use of focus groups delines to a different context as well as the verification of the comprehensibility and applicability of SIEP indicators.