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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted to REMS voluntarily consents to participate Exclusion Criteria: MMSE less than 19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapeutic security<br>assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery. | Other: Treatment as usual (TAU)<br>* 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.<br>|
| Risk Measures of Need (RISKMON)<br>assessed symptom severity, risk and protective factors for violence, global function, personality factors. | Other: Treatment as usual (TAU)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forensic, social dangerousness, therapeutic security