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Factors of Effectiveness in Italian Forensic Treatment

NCT06854133 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-06-04

No results posted yet for this 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.

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

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2030-12-31
Completion
2031-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854133 on ClinicalTrials.gov