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Evaluation of Excellence in Italy's Residence for Execution of Security Measure

Evaluation of Excellence in Italy's Residences for Execution of Security Measures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06018298
Acronym
ITAL-EE-REMS
Enrollment
245
Registered
2023-08-30
Start date
2018-07-01
Completion date
2022-12-03
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual Disability, Mild to Moderate, Mental Disorder, Personality Disorders and Disturbances in Behavior, Personality Disorders, Antisocial, Recovery, Schizophrenia and Related Disorders

Keywords

Forensic, social dangerousness, therapeutic security

Brief summary

The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed and new secure community residences for the execution of security measures (REMS) were opened in each of the 20 regions of Italy. This transition was in place by 2015. This observational study evaluates the health gains for patients both previously in OPGs and those admitted first to REMS. Health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.

Detailed description

All those detained in REMS in the twelve month period 2019 to 2020 form the reference population. Samples are assessed for symptom severity (BPRS), global function (GAF), cognitive function (MMSE), risk and protective factors for violence (HCR-20, SAPROF), personality factors (PCL-R), measures of need for therapeutic security (DUNDRUM-1), treatment response relevant to violence and mental illness (DUNDRUM-3) and forensic recovery (DUNDRUM-4). Outcome measures include violent and challenging behaviour (MOAS), length of stay, conditional (legal) discharge.

Interventions

OTHERTreatment as usual (TAU)

the components of treatment as usual (TAU) are summarised and assessed by the items of the DUNDRUM-3: physical health, mental health, substance misuse, problem behaviours, self care and activities of daily living, education occupation and creativity, family and intimacy.

Sponsors

University of Dublin, Trinity College
CollaboratorOTHER
University of Bari
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* admitted to REMS * voluntarily consents to participate

Exclusion criteria

* MMSE less than 19

Design outcomes

Primary

MeasureTime frameDescription
length of stay in REMSdate of admission to REMS through study completion, an average of 18 monthstime (days) from admission to move out of REMS
Functional recoveryDate of first, second and third assessments in REMS through study completion, an average of 18 monthschange in GAF over time
violence while in REMSDate of first, second and third assessments in REMS through study completion, an average of 18 monthsMOAS in the intervals between first, second and third assessments in REMS an average of 18 months
Readmission to REMSdate of discharge from REMS to date of readmission to REMS, if any.time (days) until readmission to REMS following discharge from REMS an average of 18 months

Secondary

MeasureTime frameDescription
conditional dischargedate of assessment to date of conditional discharge an average of 18 monthstime (days) from date of assessment to date of conditional discharge

Other

MeasureTime frameDescription
Deathfrom date of admission to date of death while in REMS, if any up to two yearsdeath while in REMS, if any

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026