Incidental findings on brain MRI in patients with first-episode and chronic psychosis.

Brain incidental findings (IFs) are unexpected brain abnormalities detected by a structural magnetic resonance (MRI) examination. We conducted a study to assess whether brain IFs are associated with first-episode psychosis (FEP) and chronic psychosis (affective vs. non-affective) compared to healthy controls (HC). Chi-squared analyses were run to compare the frequency of several IFs across groups. Logistic regression analyses were run to explore the association between group and IFs, accounting for sex, age, MRI field strength. We observed a higher frequency of most IFs in both FEP and chronic psychosis groups compared to HC, however most of the chi-squared tests did not reach significance. Patients with FEP and chronic psychosis were 3-4 times more likely to show deep white matter hyperintensities (WMH) than HC. Patients with FEP and affective chronic psychosis were 3-4 times more likely to show ventricular asymmetries than HC. All chronic patients were more likely to show periventricular WMH, liquoral spaces enlargements and ventricular system enlargements respectively. Our results suggest that deep WMH and ventricular asymmetries are associated with both the early and the chronic stages of psychosis, thus representing potential vulnerability factors already present before the onset of the symptoms, possibly due to neurodevelopmental insults.

Dimensional structure of first episode psychosis.

AIM: Current diagnostic systems, DSM-5 and ICD-10, still adopt a categorical approach to classify psychotic disorders. The present study was aimed at investigating the structure of psychotic symptomatology in both affective and non-affective psychosis from a dimensional approach. METHODS: Participants with a first episode psychosis (FEP) were recruited from a cluster-randomized controlled trial (GET-UP PIANO TRIAL), offered to all Community Mental Health Centres (CMHCs) located across two northern Italian regions. After clinical stabilization, patients were assessed with a comprehensive set of psychopathological measures including the Positive and Negative Syndrome Scale, the Hamilton Depression Rating Scale and the Bech-Rafaelsen Mania Rating Scale. A two-step cluster analysis was performed. RESULTS: Overall, 257 FEP patients (male, n = 171, 66.5%; mean age = 24.96 ± 4.56) were included in the study. The cluster analysis revealed a robust four-cluster solution: delusional-persecutory (n = 82; 31.9%), depressed (n = 95; 37%), excited (n = 26; 10.1%) and negative-disorganized (n = 54; 21%), thus suggesting a quadripartite structure with both affective and non-affective dimensions. Among non-affective dimensions, negative and disorganization symptoms constituted a unique construct apart from positive symptoms. CONCLUSIONS: Symptom dimensions may represent a useful tool for dissecting the indistinct and non-specific psychopathology of FEP in order to better target specific interventions.

Family Burden, Emotional Distress and Service Satisfaction in First Episode Psychosis. Data from the GET UP Trial.

Background: Literature has documented the role of family in the outcome of chronic schizophrenia. In the light of this, family interventions (FIs) are becoming an integral component of treatment for psychosis. The First Episode of Psychosis (FEP) is the period when most of the changes in family atmosphere are observed; unfortunately, few studies on the relatives are available. Objective: To explore burden of care and emotional distress at baseline and at 9-month follow-up and the levels of service satisfaction at follow-up in the two groups of relatives (experimental treatment EXP vs. treatment as usual TAU) recruited in the cluster-randomized controlled GET UP PIANO trial. Methods: The experimental treatment was provided by routine public Community Mental Health Centers (Italian National Health Service) and consisted of Treatment as Usual plus evidence-based additional treatment (Cognitive Behavioral Therapy for psychosis for patients, Family Intervention for psychosis, and Case Management). TAU consisted of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management and informal support/educational sessions for families. The outcomes on relatives were assessed by the Involvement Evaluation Questionnaire (IEQ-EU), the General Health Questionnaire (GHQ-12), and the Verona Service Satisfaction Scale (VSSS-EU). Differences within and between groups were evaluated. Results: At baseline, 75 TAU and 185 EXP caregivers were assessed. In the experimental group 92% of relatives participated in at least 1 family session. At follow-up both groups experienced improvement in all IEQ and GHQ items, but caregivers belonging to the EXP arm experienced a significantly greater change in 10 IEQ items (mainly pertaining to the "Tension" dimension) and in GHQ items. Due to the low sample size, a significant effectiveness was only observed for 2 IEQ items and 1 GHQ-12 item. With respect to VSSS data at follow-up, caregivers in the EXP arm experienced significantly greater satisfaction in 8 items, almost all pertaining to the dimensions "Relatives' Involvement" and "Professionals' Skills and Behavior." Conclusions: The Family intervention for psychosis delivered in the GET UP PIANO trial reduced family burden of illness and improved emotional distress and satisfaction with services. These results should encourage to promote FIs on caregivers of first-episode psychosis patients.

Predictors and moderators of treatment outcome in patients receiving multi-element psychosocial intervention for early psychosis: results from the GET UP pragmatic cluster randomised controlled trial.

BackgroundThe GET UP multi-element psychosocial intervention proved to be superior to treatment as usual in improving outcomes in patients with first-episode psychosis (FEP). However, to guide treatment decisions, information on which patients may benefit more from the intervention is warranted.AimsTo identify patients' characteristics associated with (a) a better treatment response regardless of treatment type (non-specific predictors), and (b) a better response to the specific treatment provided (moderators).MethodSome demographic and clinical variables were selected a priori as potential predictors/moderators of outcomes at 9 months. Outcomes were analysed in mixed-effects random regression models. (Trial registration: ClinicalTrials.gov, NCT01436331)ResultsAnalyses were performed on 444 patients. Education, duration of untreated psychosis, premorbid adjustment and insight predicted outcomes regardless of treatment. Only age at first contact with the services proved to be a moderator of treatment outcome (patients aged ⩾35 years had greater improvement in psychopathology), thus suggesting that the intervention is beneficial to a broad array of patients with FEP.ConclusionsExcept for patients aged over 35 years, no specific subgroups benefit more from the multi-element psychosocial intervention, suggesting that this intervention should be recommended to all those with FEP seeking treatment in mental health services.

[Use of regional health administrative databases to estimate the prevalence of mental disorders and health service utilization in a Local Health Unit of Tuscany Region (Central Italy)]. / Uso dei flussi informativi sanitari regionali per stimare la prevalenza dei disturbi mentali e il ricorso ai servizi sanitari nella popolazione di una Asl della Toscana.

OBJECTIVES: prevalence estimation of mental disorders and mental health services (SSM) utilization in 2011, using the administrative regional health databases (hospital discharge records, pharmaceutical prescriptions) and the Regional Database on Mental Health (SIRSM). STUDY DESIGN: descriptive population-based study. SETTING AND PARTICIPANTS: residents in a Local Health Unit (Florence) of Tuscany Region (Central Italy) who have access to SSM and/or to hospital departments of psychiatry/neuropsychiatry and/ or have psycholeptic/psychoanalectic prescriptions. MAIN OUTCOME MEASURES: frequencies; crude and age-standardized prevalence of patients who have access to the SSM or have admission to a hospital psychiatric ward or have psycholeptic/psychoanalectic prescriptions. RESULTS: a high prevalence (11.2%) of residents had at least one contact with health services for mental health problems, mostly (84%) for drug prescriptions only (20% of patients had a unique prescription during 2011). Depression is the most important disease (9.8% of residents had at least one prescription of antidepressants); mood disorders are the most common cause of adult access to SSM (35%-36%) and hospitalization in psychiatric ward (about 36% of admissions). Only a small proportion (about 15%) of patients with mental health problems have access to the SSM, presumably those with more severe diseases. CONCLUSIONS: results show that the information of the SIRSM database, together with pharmaceutical prescriptions (psycholeptic/ psychoanalectic) and hospitalisation in psychiatric ward, is a useful tool for assessing the prevalence of mental health problems in a population.

Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants.

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.

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. 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 enrollment 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.

[New users of mental health services for adults in Tuscany (Italy). Characteristics of cases and pathways of care]. / Nuova utenza dei Servizi di Salute Mentale per adulti della Toscana. Caratteristiche dei casi e percorsi della presa in carico.

The aim of this cross-sectional study was to describe the characteristics and pathways of care for users ("first visits") of adult mental health services in Tuscany. A questionnaire was mailed to healthcare workers of mental health services in Tuscany. Overall 184 psychiatrists and psychologists replied (136 psychiatrists and 48 psychologists) Sixty three percent of new users of mental health services were female, 32.6% were aged 18 to 34 years (32.6%) and 4.4% were foreign-born. Waiting times were lower for seeing a psychiatrist with respect to a psychologist (9.0 days ± 8.5 versus 19.2 days ± 18.7; p < 0.001). Severity of disease was the main reason for accepting persons presenting to the mental health services as patients; this occurred in 87% of cases. Persons accepted as patients were younger (42.2 years ± 14.9 versus 51.0 years ± 20.9; p < 0.05) and had an earlier onset of symptoms with respect to those not accepted as patients (32.1 years ± 15.2 vs 39.7 years ± 19.7; p < 0.05). The average duration of the mental disorder at the time of contact with the mental health service was 10.1 years and only 1/3 contacted the health service within one year of onset of the mental disorder. In conclusion, the duration of the mental disorder of adult patients contacting mental health services is high. This highlights the need for the various community agencies (e.g social services, health agencies, etc.) to facilitate access to care for people with a mental disorder.

[The treatment of acute psychotic episode: discrepancy between routine practice and evidence. The Project SIEP-DIRECT'S]. / Il trattamento dell'episodio psicotico acuto: discrepanze fra pratiche di routine ed evidenze. Il Progetto SIEP-DIRECT'S.

AIMS: To evaluate the quality of psychiatric care during the acute psychotic episode and the early post-acute period. METHODS: Data concerning 24 indicators, drawn from NICE recommendations, were collected in 19 Departments of Mental Health, in the frame of the SIEP-DIRECT'S Project to evaluate the implementation of NICE recommendations in Italian Mental Health Services. RESULTS: The treatment of the acute episode in the Italian Mental Health Services is not based only on admissions in Psychiatric Ward in General Hospitals, but also on intensive home based care. The utilization of day hospital facilities for treating acute episodes is less frequent, as the presence of home based follow up after discharge. About 3/4 of Departments of Mental Health did not have clinical guidelines concerning the pharmacological treatment in this area. However usually the standard practices followed NICE recommendations in terms of prescribed dosages, monitoring side effects and rationale for shifting to atypical antipsychotic drugs. Antipsychotic drugs, atypical or conventional, were frequently prescribed concurrently, while utilization of atypical antipsychotic drugs was increasing. CONCLUSIONS: The results show critical points concerning on one hand the scarce diffusion of clinical guidelines, on other hand the connection between standard practices, clinical guidelines and marketing of atypical antipsychotic drugs. It should be reinforced the role of the community and particularly at service level the capacity of community mental health teams to treat the acute patients.

[Care across all phases of schizophrenia and initiation of treatment: discrepancy between routine practice and evidence. The SIEP-DIRECT'S Project]. / Elementi comuni dell'assistenza in ciascuna delle fasi della schizofrenia e specificità nell'esordio: discrepanze fra pratiche di routine ed evidenze. Il progetto SIEP-DIRECT'S.

AIMS: To evaluate the quality of psychiatric care in Italian community-based services and the discrepancy between real practices and NICE recommendations for the treatment of schizophrenia concerning the elements common to all phases of care and the first episode of psychosis. METHODS: Data concerning 14 indicators on common aspects of care in all phases and 11 indicators concerning psychosis onset, drawn from NICE Recommendations, were collected in 19 Departments of Mental Health. RESULTS: An optimistic attitude seems to prevail in the staff in all phases of care, while remarkable discrepancies between service practice and recommendations have been found in relation to systematic assessment, availability of informative leaflets and support to relatives. Concerning the treatment of first episode, a lack of specific services and differentiated activities, and paucity of practices based on specific guidelines has been detected. However, Italian community based services proved to have a good capacity to provide help quickly to those seeking help for a psychotic onset, to maintain regular contact with them in the subsequent year, and provide pharmacological treatment reasonably in line with the scientific evidence. Instead, little specific support is provided to the relatives. CONCLUSIONS: The results show critical points concerning capacity of assessment and treatment standardization, in all aspects of care and specifically in the treatment for the first episode. Differentiation of activities specifically dedicated to the patients at their first episode should be promoted as well as strategies to support relatives in a more specific way.

[The acceptability of the NICE recommendations for schizophrenia in the Italian Departments of Mental Health. The SIEP-DIRECT'S Project on the discrepancy between routine practice and evidence]. / L'accettabilità delle raccomandazioni NICE per la schizofrenia nei Dipartimenti di Salute Mentale Italiani. Il Progetto SIEP- DIRECT'S sulle discrepanze fra pratiche di routine ed evidenze.

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.