Ireland
--:--IST
Latest
Clinical Trials in Italy / NCT06854133
Active, not recruiting Observational

Factors of Effectiveness in Italian Forensic Treatment

NCT06854133 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-01
Last updated
2026-06-04

Condition(s) studied

Forensic Psychiatric PatientsNot Guilty by Reason of Insanity (NGRI)Incompetent to Stand Trial (IST)Psychotic DisordersCommunity-based Forensic TreatmentViolent Behaviour and RecidivismSecurity Measures (Custodial and Non-custodial

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dipartimento Interdisciplinare Di Medicina, Psichiatria Forense E Criminologia Bari Ba

More University of Bari trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06854133 on ClinicalTrials.gov ↗ ← All trials in Italy