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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018298
Other study ID # ITAL-EE-REMS
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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 allClick 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
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