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Which country handles mentally ill offenders better? a Head-to-Head study

NCT ID NCT06854133

Knowledge-focused Sponsor: University of Bari Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 600 mentally ill offenders in Italy and California over three years to compare two very different treatment systems. Italy uses community-based care, while California relies on long-term hospital stays. Researchers will track violence, recovery, and functioning to see which model leads to better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal which aspects of forensic mental health care (community-based vs. hospital-based) work best, guiding improvements in treatment and reducing repeat offenses.
What could go wrong
This is an observational study, not a controlled experiment, so differences in outcomes may be due to factors other than the treatment model. Results may not apply to other regions or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of mentally ill offenders, with total or partial mental infirmity, entering Italian forensic care settings (Group I: REMS or non-custodial forensic settings) or Californian hospital forensic facilities (Group C) for the first time during the enrolment period. The Italian sample will be recruited through the national network of Departments of Mental Health (DSM) and forensic structures (REMS and community forensic services) participating in the study, coordinated through the Regional Single Contact Points (P.U.R.) established under the 2022 Unified Conference Agreement no. 188/CU. The Californian sample will be recruited through the Department of State Hospitals (DSH) network under the coordination of Prof. Katherine Warburton.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psychotic disorder Psychotic Disorders Recidivism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-based forensic treatment Forensic psychiatric patients Incompetent to stand trial (IST) Not guilty by reason of insanity (NGRI) Psychotic disorders Security measures (custodial and non-custodial Violent behaviour and recidivism

Contacts and locations

Locations

  • Dipartimento Interdisciplinare Di Medicina, Psichiatria Forense E Criminologia

    Bari, Ba, 70121, Italy

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