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Comparison of the Italian and U.S. Forensic Models for Dual-diagnosis Offenders: a 3-year Longitudinal Study

6 mai 2026 mis à jour par: Felice Carabellese, University of Bari

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Type d'étude

Observationnel

Inscription (Estimé)

600

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Violent Recidivism Risk
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Felice F. Carabellese, Medical doctor, Full Professor, University of Bari Aldo Moro

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2029

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • prot. 2237/CEL

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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