- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07585656
Comparison of the Italian and U.S. Forensic Models for Dual-diagnosis Offenders: a 3-year Longitudinal Study
Comparison of the Italian and US Forensic Models Regarding Dual Diagnosis Offenders: a 3-year Longitudinal Study
This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81/2014 led to the establishment of a community-based forensic system centered on REMS (Residences for the Execution of Security Measures), integrated within the National Health Service. This model seeks to limit institutionalization and promote rehabilitative pathways in community settings. However, it continues to face challenges related to limited bed availability, waiting lists, and the complex management of social dangerousness. In contrast, the U.S. system, particularly in California, is characterized by high-security forensic psychiatric hospitals with large capacities, but also presents issues such as prolonged hospitalizations, an aging patient population, and a high prevalence of substance use disorders.
Dual diagnosis, defined as the co-occurrence of psychiatric disorders and substance use disorders, is highly prevalent in forensic populations and is associated with increased clinical complexity, higher risk of recidivism, and poorer treatment outcomes. Neurobiological and psychological mechanisms underlying addiction-including dysfunctions in the dopaminergic reward system, craving processes, and impairments in executive functioning-contribute to reduced behavioral control and increased impulsivity. Theoretical models such as the self-medication hypothesis and multifactorial frameworks suggest that substance use may both exacerbate psychiatric symptoms and represent an attempt to regulate them.
Given these complexities, integrated treatment approaches that combine psychiatric care and addiction interventions are essential, particularly in forensic settings. The present study includes offenders with mental illness in forensic care systems in Italy and California, encompassing both custodial and non-custodial settings. Participants will be followed over a three-year period, with assessments conducted at 12, 24, and 36 months. The methodology involves the use of standardized instruments to evaluate psychopathological severity, global functioning, risk of violent recidivism, protective factors, treatment adherence, impulsivity, and substance use. Data on clinical outcomes, antisocial behaviors, and discharge conditions will also be collected.
The primary objectives of the study are to describe and compare the clinical, demographic, and criminological profiles of forensic populations with dual diagnosis; to examine treatment pathways and outcomes; to identify indicators of treatment effectiveness; and to evaluate both risk and protective prognostic factors, as well as their predictive value for recidivism and clinical trajectories.
The expected impact of the study lies in improving the understanding of differences between community-based and hospital-based forensic models, with the goal of identifying integrated strategies capable of enhancing rehabilitation, reducing recidivism, and improving long-term outcomes. Findings may contribute to the development of more effective and individualized treatment approaches, as well as inform health and judicial policies aimed at better integrating clinical care and risk management in dual diagnosis forensic populations.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Felice F. Carabellese, Medical doctor, Full Professor
- Telefonní číslo: +39330673152
- E-mail: felicefrancesco.carabellese@uniba.it
Studijní záloha kontaktů
- Jméno: Bernardo Bozza, Medical Doctor, psychiatrist
- Telefonní číslo: +393406740680
- E-mail: bernardo.bozza@uniroma1.it
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
The study population consists of adult offenders with mental disorders recruited from forensic psychiatric care systems in Italy and California. Participants are enrolled at the time of the application of a security measure or upon admission to a forensic facility, including both custodial and non-custodial settings.
In the Italian cohort, participants include individuals placed under security measures within the National Health Service, such as those admitted to REMS or managed in community-based forensic or psychiatric services. This group reflects the community-oriented Italian forensic model, characterized by rehabilitative pathways and integration with territorial mental health services.
In the California cohort, participants are recruited from high-security forensic hospitals and community forensic programs under the Department of State Hospitals, including individuals deemed incompetent to stand trial (IST) or not guilty by reason of insanity (NGRI). This population reflects a h
Popis
Inclusion Criteria:
- Adults aged 18 years or older.
- Individuals admitted to forensic psychiatric care in Italy or California.
- Presence of a diagnosed mental disorder according to DSM-5 / ICD criteria.
- Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition.
- Placement in one of the study settings:
Italy: REMS or other forensic/community facilities under custodial or non-custodial security measures; California: Department of State Hospitals forensic facilities.
- Ability to provide written informed consent, or consent provided through a legal guardian when applicable.
- Availability for longitudinal follow-up at 12, 24, and 36 months.
Exclusion Criteria:
- Absence of a confirmed psychiatric disorder.
- Absence of current or lifetime Substance Use Disorder.
- Non-forensic psychiatric patients without criminal justice involvement.
- Severe cognitive impairment or neurological condition preventing valid assessment.
- Acute medical or psychiatric instability that makes participation temporarily impossible.
- Inability to complete the assessment procedures, even with support or adapted administration.
- Refusal to participate or withdrawal of informed consent. Insufficient clinical, forensic, or follow-up data for longitudinal analysis.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Violent Recidivism Risk
Časové okno: from enrollment at 3 years
|
The risk of violent recidivism will be assessed longitudinally using structured professional judgment approaches, integrating dynamic clinical, historical, and risk management factors.
Changes over time will be analyzed to evaluate the impact of treatment and system-related variables on future violence risk.
|
from enrollment at 3 years
|
|
Clinical Improvement (Psychopathology)
Časové okno: from enrollment to 3 years
|
Clinical severity will be measured through standardized psychiatric rating scales, capturing changes in psychopathological symptoms across the follow-up period.
This outcome reflects the effectiveness of treatment in reducing symptom burden and improving mental stability.
|
from enrollment to 3 years
|
|
Substance Use Severity and Relapse
Časové okno: from enrollment to 3 years
|
Substance use severity and relapse will be evaluated using validated screening tools and clinical data, focusing on patterns of use, reduction, and recurrence over time.
This outcome is central to understanding the trajectory of dual diagnosis and its interaction with clinical and forensic outcomes.
|
from enrollment to 3 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Felice F. Carabellese, Medical doctor, Full Professor, University of Bari Aldo Moro
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- prot. 2237/CEL
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .