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

NCT ID: NCT06018298

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2022-12-03

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Therapeutic security

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

Treatment as usual (TAU)

Intervention Type 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)

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

Treatment as usual (TAU)

Intervention Type 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.

Interventions

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Treatment 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* admitted to REMS
* voluntarily consents to participate

Exclusion Criteria

* MMSE less than 19
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dublin, Trinity College

OTHER

Sponsor Role collaborator

University of Bari

OTHER

Sponsor Role lead

Responsible Party

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Felice Carabellese

Full Professor of Forensic Psychopathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felice F Carabellese, MD

Role: STUDY_DIRECTOR

University of Bari

Lia Parente, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Harry G Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin Trinity College (TCD)

Mary Davoren, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin Trinity College (TCD)

Locations

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University of Bari

Bari, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 35861358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21410967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31122631 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 27766115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32482202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27256003 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30026395 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 32141478 (View on PubMed)

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

Reference Type 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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type DERIVED
PMID: 39488677 (View on PubMed)

Other Identifiers

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ITAL-EE-REMS

Identifier Type: -

Identifier Source: org_study_id

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