Factors of Effectiveness in Italian Forensic Treatment

NCT06854133 | Not Yet Recruiting

• 1 other identifier: REMS FEIFT
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Over the last few years, in Italy, the treatment of the mentally ill offender has undergone profound changes following a series of successive legislative interventions. Lastly, Law no. 81 of 30 May 2014 decreed the closure of the 6 active high-security psychiatric hospitals (Ospedali Psichiatrici Giudiziari = OPG), opting for a new model of forensic care. The new Italian forensic treatment model is essentially community-based, exclusively managed by the health system, with rehabilitation and recovery purposes in the patient's home territory. Due to its characteristics, it is unique in the Western world. In California, the forensic treatment model is defined by the California Penal Code. The Department of State Hospitals (DSH) oversees the care and security pathways of individuals deemed not criminally responsible by reason of mental disorder (NGRI) or incompetent to stand trial (IST). Care pathways are organized around the secure hospital, with the largest number of beds in high-security hospitals. There are also community-based forensic facilities. The average length of stay is 10 years, two-thirds of which is in the hospital. The forensic treatment models of the two countries considered are, therefore, very different from each other, each with specific strengths and weaknesses. Some national data (Catanesi et al, 2019) show that the length of stay in Italian community forensic facilities intended to exclusively accommodate people subject to detention security measures (Residences for the Execution of the Security Measure = REMS) is much shorter than in California. Furthermore, REMS do not have the same standardization of safety procedures to be followed that is observed in Californian hospitals, whether it concerns structural measures, relational measures, or professional services. There is instead a greater use of psychotherapeutic treatments and rehabilitative and occupational activities. Some experiential data seem to indicate, however, some specific outcome indicators in REMS that suggest greater forensic treatment efficacy compared to Californian forensic hospital facilities. The differences between the two countries raise important questions about the clinical, therapeutic, and social factors that may be relevant in the forensic recovery process. Understanding the nature of these questions may illustrate a more generalizable understanding of the factors that help people receiving forensic care recover and regain successful social reintegration in a safe manner. Understanding the similarities and contrasts between the two different treatment settings of California and Italy is the primary goal of this study. Despite the diversity of the forensic models of the two countries considered, we intend to compare the two different treatment realities by enrolling a national sample of Italian forensic patients (Group I) and a sample of forensic patients from the State of California (Group C) of equal numbers, to then follow them both for three years with annual check-ups. Starting from a similar starting time T0 for both patient samples, using the same risk assessment and clinical tools, the same data collection form common to the models of the two countries (containing personal, work, anamnestic, clinical, and judicial data) and a specific treatment evaluation form (quality and type of pharmacological treatment; level of adherence to pharmacological treatment; awareness of the disease and level of adaptation to the treatment measures; quality of the rehabilitation measures chosen; any psychotherapies; family support during the project; commitment to socially useful or work-related activities; economic support), the enrolled patients will be followed for three years starting from time T0 through annual periodic check-ups. The admission criteria differ between the Californian and Italian systems. However, some patients are similar in diagnosis and type of crime committed. Focusing on patients with similar diagnoses and type of crime committed will allow us to understand the differences that we expect to observe in the different care models. Therefore, for the purposes of comparison, we will focus on patients with diagnoses of psychotic disorder and mental disorder with respect to the crime committed.

Conditions

Forensic Psychiatric Patients

Outcome Measures

Primary Outcomes (1)

• Lenght of stay in REMS

  The length of stay in the REMS with unconditional discharge

  from 12.01.2025 to 12.01.2028

Study Arms (2)

Italian forensic patients

Italian forenisc patients

Californian Forensic patients

Californian forensic patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The aim is ultimately to develop reliable and scientifically sound strategies and tools for predicting forensic treatment efficacy and to verify whether and how indications from other countries with different healthcare organizations can also be applied in Italy and vice versa.

You may not qualify if:

• less than MMSE 18 score

Sponsors & Collaborators

• University of Bari: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Full Professor in Forensic Psychiatry

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2025

Record last verified: 2025-02