The BoTPT also collaborates with other psychiatric services and University departments in Italy on the topic of migration and mental health. These collaborations are performed in order to understand the occurrence of different disorders in relation to specific cultural contexts, the different migratory movements in different areas, as well as the specific models of care. An initial investigation involving four Italian centres revealed important differences in pathways to care and the socio-demographic characteristics of migrants attending psychiatric services [ 26 ]. The study has the following secondary aims: 1 to understand risk and protective factors for the development of psychotic disorders in migrants; 2 to evaluate the link between psychopathology of psychotic disorders in migrants and socio-demographic characteristics, migration history, life experiences; 3 to assess the clinical and social outcome of FEP in migrants.
The PEP-Ita migration project is a prospective observational study over a two-year period 1 January —31 December Data collection will be carried out through a central computerized system. Twenty-four months after the survey period, we will conduct a leakage study to identify any subject that may have been missed during the critical data collection period. In order to do so, we will review all new mental health service registration forms and will interrogate the computerized information systems.
The study will include untreated first-generation migrants with FEP who seek treatment for the first time at participating mental health centres during the recruitment period. In order to ensure that patients have not yet presented and been treated for a psychotic episode, an accurate medical history will be recorded together with patients and, where necessary, with their families. Previous use of medications or other therapeutic strategies will be the object of a strict survey.
The inclusion criteria for the study population are: 1 diagnosis of a psychotic episode, defined on the basis of the criteria currently in use Diagnostic and Statistical Manual of Mental Disorders - DSM-IV-TR [ 37 ]; 2 age between 18 and 64; 3 patients living in the study area of the involved mental health centres; 4 patients who accept to participate in the study and sign a valid informed consent. The inclusion criteria for control native patients are the same as migrants: thus, all native patients consecutively presenting a first-episode psychosis and admitted to the designated psychiatric services for each study centre in the recruitment period 1 January —31 December will be recruited as controls.
Because of these recruitment criteria, control native patients will not be matched to migrant patients, and we will not be able to predict the number of controls until the recruitment process is concluded. For each patient, the following information will be collected: 1.
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Informed consent; 2. Socio-demographic data gender, birth date and place, ethnicity, marital status, educational level, employment status, housing status. As regards the optional levels of study, the evaluations will be performed by the use of a wide series of tests derived from the EU-GEI protocol [ 39 ] and by other research experiences of the participating centres.
Amended Bullying Questionnaire [ 47 ] to assess acts of bullying by peers emotional, psychological or physical violence inflicted on the subject before the age of 17;. Harvard Trauma Questionnaire HTQ [ 48 ] to investigate traumatic experiences that occurred during adult life;. The Built Environment Assessment Tool BEAT [ 49 ] allows the classification of the area of residence of the subject on the basis of a set of architectural evaluation criteria and available infrastructure.
Discrimination Questionnaire [ 50 ], a modified item scale for significant and everyday elements of interpersonal discrimination;.
Cannabis Experiences Questionnaire CEQ [ 51 ] to investigate the intake of cannabis and the subjective experience which results;. Schedules for Clinical Assessment in Neuropsychiatry SCAN [ 55 ] to obtain a standardized diagnosis and assess the psychopathology in detail;. Assessments will be carried out by psychiatrists or clinical psychologists appropriately trained in the use of the above-mentioned assessment instruments.
In case of relevant linguistic barriers, a cultural mediator will join the clinical researcher: however, research questionnaires have been translated into several languages English, French, German, Dutch, Spanish, Portuguese, Turkish, Serbian through a back-translation process. This will help the direct assessment of the patient, confining the presence of cultural mediators only to those cases where migrants have significant linguistic barriers and instruments in their own language are not available.
Data will be entered into a computerized database, which will be accessible online by all centres participating in the study. There will be two types of profile: user profiles and admin profiles. These functions enable a constant monitoring of the work evolution by centralizing data and enabling real-time and accurate assessment of the study course, solicitation of the participants, and correction of possible errors.
After a full explanation of the nature of the study, subjects will be asked to participate in the study, and if they accept, they will be asked to sign the informed consent form. Subjects will be ensured that all data remain anonymous. Intelligence about the participation of the patient will not be included in their medical record. Identification codes will be assigned to each subject in order to protect their confidentiality and ensure all data remain anonymous.
The subjects may withdraw from the study at any time. It is also considered right of the study to use the data acquired in seminars, conferences, and scientific publications.
There are no predictable side effects that can be attributed to the participation in this study. Patients will continue to receive their usual therapies, and any adverse events that occur during the administration of therapeutic procedures will be notified to the authorities in accordance with the applicable laws. The research study described does not present any particular ethical problems. The study will gather relevant information on the socio-demographic and clinical features, and pathways to care of migrants with first-episode psychosis in Italy.
The comparison with native patients will highlight specific risk factors for psychosis in migrants. As a future perspective, it would be an interesting additional research field a case—control study with migrants who, having been recruited in the same catchment areas at the same period of data collection, have not developed psychosis. Finally, the inclusion of mental health centres located in different social and geographic areas will allow inter-regional comparisons of risk factors for psychosis in migrants. Selected centres will be able to obtain more in-depth information on both individual and area-specific social risk factors, as well as an evaluation of the family burden of patients with a psychotic onset.
We expect that the results of this study will contribute to the development of prevention programs for psychosis in migrants and will help to improve the effectiveness of early intervention treatments within migrant population. IT is the network main coordinator, the main study-designer and manuscript writer. AF is a network co-coordinator and has significantly collaborated to the study design and the manuscript draft.
MB is a network co-coordinator and has collaborated to the data collection and the manuscript draft. MCD is our Information Technology Supervisor, he has created the online database and will perform statistical analyses. All authors read and approved the final manuscript. We acknowledge the contribution of Dr. Craig Morgan and Prof. We also deeply thank Dr.
A special thanks goes to Prof. Dinesh Bhugra and to Dr. Jane Boydell for their suggestions on methodology and research strategy in cultural psychiatry and psychiatric epidemiology. Simone Vender. National Center for Biotechnology Information , U. BMC Psychiatry. Published online Jun Silvia Ferrari 10 U. Marcello Nardini 11 U. Corinna Reggianini 10 U. Marco Rigatelli 10 U. Orlando Todarello 11 U.
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