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

NCT06018298 | Completed DMC

• 1 other identifier: ITAL-EE-REMS
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• length of stay in REMS

  time (days) from admission to move out of REMS

  date of admission to REMS through study completion, an average of 18 months

• Functional recovery

  change in GAF over time

  Date of first, second and third assessments in REMS through study completion, an average of 18 months

• violence while in REMS

  MOAS in the intervals between first, second and third assessments in REMS an average of 18 months

  Date of first, second and third assessments in REMS through study completion, an average of 18 months

• Readmission to REMS

  time (days) until readmission to REMS following discharge from REMS an average of 18 months

  date of discharge from REMS to date of readmission to REMS, if any.

Secondary Outcomes (1)

• conditional discharge

  date of assessment to date of conditional discharge an average of 18 months

Other Outcomes (1)

• Death

  from date of admission to date of death while in REMS, if any up to two years

Study Arms (2)

Therapeutic security

assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery.

Other: Treatment as usual (TAU)

Risk Measures of Need (RISKMON)

assessed symptom severity, risk and protective factors for violence, global function, personality factors.

Other: Treatment as usual (TAU)

Interventions

Treatment as usual (TAU) OTHER

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.

Risk Measures of Need (RISKMON); Therapeutic security

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• admitted to REMS
• voluntarily consents to participate

You may not qualify if:

• MMSE less than 19

Sponsors & Collaborators

• University of Bari: lead
• University of Dublin, Trinity College: collaborator

Study Sites (1)

University of Bari

Bari, 70124, Italy

Location

Related Publications (16)

• 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.

  PMID: 35861358 BACKGROUND

• 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.

  PMID: 21410967 BACKGROUND

• 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.

  PMID: 31122631 BACKGROUND

• KENNEDY, H. G. 2002. Therapeutic uses of security: mapping forensic mental health services by stratifying risk. Advances in Psychiatric Treatment, 8, 433-443.DOI: https://doi.org/10.1192/apt.8.6.433

  BACKGROUND

• O'Neill C, Smith D, Caddow M, Duffy F, Hickey P, Fitzpatrick M, Caddow F, Cronin T, Joynt M, Azvee Z, Gallagher B, Kehoe C, Maddock C, O'Keeffe B, Brennan L, Davoren M, Owens E, Mullaney R, Keevans L, Maher R, Kennedy HG. STRESS-testing clinical activity and outcomes for a combined prison in-reach and court liaison service: a 3-year observational study of 6177 consecutive male remands. Int J Ment Health Syst. 2016 Oct 11;10:67. doi: 10.1186/s13033-016-0097-z. eCollection 2016.

  PMID: 27766115 BACKGROUND

• Williams HK, Senanayke M, Ross CC, Bates R, Davoren M. Security needs among patients referred for high secure care in Broadmoor Hospital England. BJPsych Open. 2020 Jun 2;6(4):e55. doi: 10.1192/bjo.2020.35.

  PMID: 32482202 BACKGROUND

• Carabellese F, Felthous AR. Closing Italian Forensic Psychiatry Hospitals in Favor of Treating Insanity Acquittees in the Community. Behav Sci Law. 2016 Mar;34(2-3):444-59. doi: 10.1002/bsl.2234.

  PMID: 27256003 BACKGROUND

• Catanesi R, Mandarelli G, Ferracuti S, Valerio A, Carabellese F (2019). The new Italian residential forensic psychiatric system (REMS). A one-year population study. Italian Journal of Criminology - Special Number, Vol.13.

  BACKGROUND

• Cura e controllo. Come cambia la pericolosità sociale psichiatrica R Catanesi, FF Carabellese, I Grattagliano - Giornale Italiano di Psicopatologia, 2009

  BACKGROUND

• 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.

  PMID: 30026395 BACKGROUND

• Comportamento violento in una coorte di pazienti psichiatrici: rischio psicosociale e fattori protettivi F Carabellese, C Candelli, D La Tegola, R Buzzerio… - Rassegna italiana di criminologia, 2015

  BACKGROUND

• 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.

  PMID: 32141478 BACKGROUND

• OPG di chiusura: strumenti diagnostici per criminali malati di mente socialmente pericolosi. Dalla valutazione medico-psichiatrica al trattamento F Carabellese - Rassegna Italiana di Criminologia, 2017

  BACKGROUND

• Assessing the needs of patients in secure settings: a multi-disciplinary approach P Pierzchniak, F Farnham, N Taranto, D Bull, H Gill… - The Journal of Forensic Psychiatry, 1999

  BACKGROUND

• Models of care in forensic psychiatry HG Kennedy - BJPsych Advances, 2022

  BACKGROUND

• Parente L, Carabellese F, Felthous A, La Tegola D, Davoren M, Kennedy HG, Carabellese FF. Italian Evaluation and Excellence in REMS (ITAL-EE-REMS): appropriate placement of forensic patients in REMS forensic facilities. Int J Ment Health Syst. 2024 Nov 2;18(1):33. doi: 10.1186/s13033-024-00647-5.

  PMID: 39488677 DERIVED

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Personality Disorders; Antisocial Personality Disorder; Intellectual Disability

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Study Officials

• Felice F Carabellese, MD

  University of Bari

  STUDY DIRECTOR

• Lia Parente, PsyD

  University of Bari

  PRINCIPAL INVESTIGATOR

• Harry G Kennedy, MD

  University of Dublin Trinity College (TCD)

  PRINCIPAL INVESTIGATOR

• Mary Davoren, MD

  University of Dublin Trinity College (TCD)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 30, 2023
• Study Start: July 1, 2018
• Primary Completion: December 3, 2022
• Study Completion: December 3, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)