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

Mental Disorder Clinical Trial

— ITAL-EE-REMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018298
• Other study ID #: ITAL-EE-REMS
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 3, 2022

Study information

• Verified date: August 2023
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 3, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admitted to REMS
• voluntarily consents to participate

Exclusion Criteria:

• MMSE less than 19

Related Conditions & MeSH terms

• Antisocial Personality Disorder
• Intellectual Disability
• Mental Disorder
• Mental Disorders
• Personality Disorders
• Recovery
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	University of Bari	Bari

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari	University of Dublin, Trinity College

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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

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. — View Citation

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. — View 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. 2022 Jul 21:306624X221113531. doi: 10.1177/0306624X221113531. Online ahead of print. — View Citation

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.

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

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

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. — View 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. — View 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. — View Citation

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

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

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. — View Citation

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

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	death while in REMS, if any	from date of admission to date of death while in REMS, if any up to two years
Primary	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
Primary	Functional recovery	change in GAF over time	Date of first, second and third assessments in REMS through study completion, an average of 18 months
Primary	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
Primary	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	conditional discharge	time (days) from date of assessment to date of conditional discharge	date of assessment to date of conditional discharge an average of 18 months