Clinical trial NCT06018298: Evaluation of Excellence in Italy's Residence for Execution of Security Measure
Official title: Evaluation of Excellence in Italy's Residences for Execution of Security Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorder
Recovery
Schizophrenia and Related Disorders
Personality Disorders and Disturbances in Behavior
Personality Disorders, Antisocial
Intellectual Disability, Mild to Moderate
Keywords: Forensic
social dangerousness
therapeutic security
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
First posted: 2023-08-30
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents admitted to Residences for the Execution of Security Measures (REMS) under court orders: found by the court to be partially responsible (Penal Code 89) or completely not criminally responsible (Penal Code 88) for a crime and also found socially dangerous (Penal Code 203).

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.

Eligibility criteria: Inclusion Criteria:

* admitted to REMS
* voluntarily consents to participate

Exclusion Criteria:

* MMSE less than 19

Primary outcomes:
measure: length of stay in REMS
timeFrame: date of admission to REMS through study completion, an average of 18 months
measure: Functional recovery
timeFrame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
measure: violence while in REMS
timeFrame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
measure: Readmission to REMS
timeFrame: date of discharge from REMS to date of readmission to REMS, if any.
Secondary outcomes:
measure: conditional discharge
timeFrame: date of assessment to date of conditional discharge an average of 18 months
Other outcomes:
measure: Death
timeFrame: from date of admission to date of death while in REMS, if any up to two years
Locations:
city: Bari
country: Italy
facility: University of Bari
Study officials:
affiliation: University of Bari
name: Felice F Carabellese, MD
role: STUDY_DIRECTOR
affiliation: University of Bari
name: Lia Parente, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin Trinity College (TCD)
name: Harry G Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin Trinity College (TCD)
name: Mary Davoren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carabellese F, Parente L, Kennedy HG. Reform of Forensic Mental Health Services in Italy: Stigma and Blaming the Messenger: Hermenoia. Int J Offender Ther Comp Criminol. 2024 Nov;68(15):1505-1524. doi: 10.1177/0306624X221113531. Epub 2022 Jul 21.
citation: Flynn G, O'Neill C, McInerney C, Kennedy HG. The DUNDRUM-1 structured professional judgment for triage to appropriate levels of therapeutic security: retrospective-cohort validation study. BMC Psychiatry. 2011 Mar 16;11:43. doi: 10.1186/1471-244X-11-43.
citation: Jeandarme I, Habets P, Kennedy H. Structured versus unstructured judgment: DUNDRUM-1 compared to court decisions. Int J Law Psychiatry. 2019 May-Jun;64:205-210. doi: 10.1016/j.ijlp.2019.04.006. Epub 2019 May 1.
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citation: Carabellese F, Felthous AR, Rossetto I, La Tegola D, Franconi F, Catanesi R. Female Residents with Psychopathy in a High-Security Italian Hospital. J Am Acad Psychiatry Law. 2018 Jun;46(2):171-178. doi: 10.29158/JAAPL.003744-18.
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citation: Gualtieri G, Traverso S, Pozza A, Ferretti F, Carabellese F, Gusinu R, Coluccia A. Clinical risk management in High-Security Forensic Psychiatry Residences. Protecting patients and health professionals: perspectives and critical issues of the Law 81/2014. Clin Ter. 2020 Mar-Apr;171(2):e97-e100. doi: 10.7417/CT.2020.2196.
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