NCT06018298|CompletedDMC
Evaluation of Excellence in Italy's Residence for Execution of Security Measure
ITAL-EE-REMS
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ITAL-EE-REMS
Sponsor study identifier
observational
245
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
December 3, 2022
Actual (reported)Study Completion
December 3, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 3, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2018
Actual (reported)December 3, 2022
Actual (reported)December 3, 2022
Actual (reported)August 15, 2023
Actual (reported)August 30, 2023
Actual (reported)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
assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery.
assessed symptom severity, risk and protective factors for violence, global function, personality factors.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
University of Bari
Bari, 70124, Italy
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.
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.
Felice F Carabellese, MD
University of Bari
Lia Parente, PsyD
University of Bari
Harry G Kennedy, MD
University of Dublin Trinity College (TCD)
Mary Davoren, MD
University of Dublin Trinity College (TCD)
245 participants (actual enrollment reported by the registry).
First Submitted
August 15, 2023
First Posted
August 30, 2023
Study Start
July 1, 2018
Actual (reported)A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
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.
conditional discharge
date of assessment to date of conditional discharge an average of 18 months
Death
from date of admission to date of death while in REMS, if any up to two years
Contact the study team to confirm eligibility.
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.
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
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.
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.
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.
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.
Cura e controllo. Come cambia la pericolosità sociale psichiatrica R Catanesi, FF Carabellese, I Grattagliano - Giornale Italiano di Psicopatologia, 2009
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.
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
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.
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
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
Models of care in forensic psychiatry HG Kennedy - BJPsych Advances, 2022
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.
Primary Completion
December 3, 2022
Actual (reported)Study Completion
December 3, 2022
Actual (reported)Last Updated
September 6, 2023
Record last verified: 2023-08
In view of the sensitive nature of the data, aggregated anonymised data may be provided to accredited researchers on a case by case basis.
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