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NCT Number: NCT06018298

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

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.

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Key information

Conditions

Mental Disorder Antisocial Personality Disorder Intellectual Disability Intellectual Disability, Mild to Moderate Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personality Disorders Personality Disorders and Disturbances in Behavior Personality Disorders, Antisocial Recovery Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia and Related Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bari

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admitted to REMS
  • voluntarily consents to participate

Exclusion criteria

  • MMSE less than 19

Treatment and study plan

Treatment as usual (TAU)

Other

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.

Primary outcomes

  1. length of stay in REMS

    Time frame: date of admission to REMS through study completion, an average of 18 months

    time (days) from admission to move out of REMS

  2. Functional recovery

    Time frame: Date of first, second and third assessments in REMS through study completion, an average of 18 months

    change in GAF over time

  3. violence while in REMS

    Time frame: 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

  4. Readmission to REMS

    Time frame: 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 outcomes

  1. conditional discharge

    Time frame: 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 outcomes

  1. Death

    Time frame: from date of admission to date of death while in REMS, if any up to two years

    death while in REMS, if any

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Collaborators

  • University of Dublin, Trinity College

Registry information

Official study title

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

Acronym: ITAL-EE-REMS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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