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Active Not Recruiting
NCT06854133
Factors of Effectiveness in Italian Forensic Treatment
Conditions: Forensic Psychiatric Patients, Not Guilty by Reason of Insanity (NGRI), Incompetent to Stand Trial (IST), Psychotic Disorders, Community-based Forensic Treatment, Violent Behaviour and Recidivism, Security Measures (Custodial and Non-custodial
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Enrollment: 600
Sponsor: University of Bari
Location: Dipartimento Interdisciplinare Di Medicina, Psichiatria Forense E Criminologia Bari Ba
Summary
Over recent years, in Italy, the treatment of mentally ill offenders has undergone profound changes following successive legislative interventions, culminating in Law no. 81/2014, which closed all high-security psychiatric hospitals (OPG) and established a community-based forensic care model managed exclusively by the National Health Service. This model, centred on REMS and territorial mental health services, is unique in the Western context and emphasises rehabilitation, recovery, and time-limited custodial measures.
In California, forensic treatment is regulated by the California Penal Code and delivered mainly within high-security state hospitals coordinated by the Department of State Hospitals (DSH), with long average lengths of stay and strong standardisation of security procedures. The two systems therefore differ markedly in structure, duration of stay, and balance between security and rehabilitative goals, raising questions about their respective effectiveness in terms of clinical outcomes, functional recovery, and violent recidivism.
This multicentre, prospective cohort study compares Italian forensic patients (Group I) and Californian forensic patients (Group C), enrolled at first entry into forensic care and followed longitudinally for three years with assessments at T0, T1, T2, and T3 using harmonised tools (BPRS 4.0, WHODAS 2.0, HCR-20 V3, SAPROF, DUNDRUM Toolkit, MOAS) and a common data collection form. Primary aims include a detailed epidemiological characterisation of the Italian forensic population and a systematic comparison of outcomes between the Italian and Californian models with respect to violent recidivism, length of stay in forensic settings, clinical and functional improvement, and recovery indicators.
Comparative analyses focus on subgroups of participants with psychotic disorders and mental disorders directly related to the index offence, in order to examine differences in outcomes attributable to systemic and organisational features of the two forensic treatment models rather than to diagnostic or criminological heterogeneity.
Eligibility Criteria
Inclusion Criteria:
Group I - Italy:
All subjects subject to custodial security measures (e.g., REMS) or non-custodial security measures (e.g., supervised liberty, placement in dedicated forensic community residential facilities - CRAP), regardless of clinical diagnosis or type of offence committed
Both definitive and provisional security measures are included
Management contexts include residential, semi-residential, and community-based settings
Age ≥ 18 years
Group C - California:
Patients admitted to secure hospitals or community forensic facilities for incompetency to stand trial (IST) or not guilty by reason of insanity (NGRI), pursuant to the California Penal Code
Exclusion Criteria:
Age under 18 years
MMSE score below 18 (severe cognitive impairment preventing administration of study instruments)
Inability to provide written informed consent and absence of a legal guardian or Support Administrator available to provide substitute consent
Acute medical conditions preventing the administration of the evaluation instruments specified in the research protocol
Source: ClinicalTrials.gov (NCT06854133). StuddyBuddy aggregates publicly available trial information.