ITAL-EE-REMS: Evaluation of Excellence in Italy's Residence for Execution of Security Measure

Sponsor

University of Bari (Other)

Overall Status

Completed

CT.gov ID

NCT06018298

Collaborator

University of Dublin, Trinity College (Other)

245

Enrollment

Location

53.1

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorder Recovery Schizophrenia and Related Disorders Personality Disorders and Disturbances in Behavior Personality Disorders, Antisocial Intellectual Disability, Mild to Moderate	Other: Treatment as usual (TAU)

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

245 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Dec 3, 2022

Actual Study Completion Date :

Dec 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
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) 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.	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.

Arm

Intervention/Treatment

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)

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.

Other: Treatment as usual (TAU)

Outcome Measures

Primary Outcome Measures

length of stay in REMS [date of admission to REMS through study completion, an average of 18 months]
time (days) from admission to move out of REMS
Functional recovery [Date of first, second and third assessments in REMS through study completion, an average of 18 months]
change in GAF over time
violence while in REMS [Date of first, second and third assessments in REMS through study completion, an average of 18 months]
MOAS in the intervals between first, second and third assessments in REMS an average of 18 months
Readmission to REMS [date of discharge from REMS to date of readmission to REMS, if any.]
time (days) until readmission to REMS following discharge from REMS an average of 18 months

Secondary Outcome Measures

conditional discharge [date of assessment to date of conditional discharge an average of 18 months]
time (days) from date of assessment to date of conditional discharge

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

admitted to REMS
voluntarily consents to participate

Exclusion Criteria:

MMSE less than 19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bari	Bari		Italy	70124

Sponsors and Collaborators

University of Bari
University of Dublin, Trinity College

Investigators

Study Director: Felice F Carabellese, MD, University of Bari
Principal Investigator: 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)