xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018298</url>
    </required_header>
    <id_info>
      <org_study_id>ITAL-EE-REMS</org_study_id>
      <nct_id>NCT06018298</nct_id>
    </id_info>
    <brief_title>Evaluation of Excellence in Italy's Residence for Execution of Security Measure</brief_title>
    <acronym>ITAL-EE-REMS</acronym>
    <official_title>Evaluation of Excellence in Italy's Residences for Execution of Security Measures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Bari</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Dublin, Trinity College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Bari</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that&#xD;
        the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed&#xD;
        and new secure community residences for the execution of security measures (REMS) were opened&#xD;
        in each of the 20 regions of Italy. This transition was in place by 2015. This observational&#xD;
        study evaluates the health gains for patients both previously in OPGs and those admitted&#xD;
        first to REMS. Health gains assessed include recovery measured by symptoms, function, need&#xD;
        for therapeutic security and recovery of legal autonomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All those detained in REMS in the twelve month period 2019 to 2020 form the reference&#xD;
        population. Samples are assessed for symptom severity (BPRS), global function (GAF),&#xD;
        cognitive function (MMSE), risk and protective factors for violence (HCR-20, SAPROF),&#xD;
        personality factors (PCL-R), measures of need for therapeutic security (DUNDRUM-1), treatment&#xD;
        response relevant to violence and mental illness (DUNDRUM-3) and forensic recovery&#xD;
        (DUNDRUM-4).&#xD;
  &#xD;
        Outcome measures include violent and challenging behaviour (MOAS), length of stay,&#xD;
        conditional (legal) discharge.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2018</start_date>
    <completion_date type="Actual">December 3, 2022</completion_date>
    <primary_completion_date type="Actual">December 3, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>length of stay in REMS</measure>
      <time_frame>date of admission to REMS through study completion, an average of 18 months</time_frame>
      <description>time (days) from admission to move out of REMS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional recovery</measure>
      <time_frame>Date of first, second and third assessments in REMS through study completion, an average of 18 months</time_frame>
      <description>change in GAF over time</description>
    </primary_outcome>
    <primary_outcome>
      <measure>violence while in REMS</measure>
      <time_frame>Date of first, second and third assessments in REMS through study completion, an average of 18 months</time_frame>
      <description>MOAS in the intervals between first, second and third assessments in REMS an average of 18 months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Readmission to REMS</measure>
      <time_frame>date of discharge from REMS to date of readmission to REMS, if any.</time_frame>
      <description>time (days) until readmission to REMS following discharge from REMS an average of 18 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>conditional discharge</measure>
      <time_frame>date of assessment to date of conditional discharge an average of 18 months</time_frame>
      <description>time (days) from date of assessment to date of conditional discharge</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Death</measure>
      <time_frame>from date of admission to date of death while in REMS, if any up to two years</time_frame>
      <description>death while in REMS, if any</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">245</enrollment>
    <condition>Mental Disorder</condition>
    <condition>Recovery</condition>
    <condition>Schizophrenia and Related Disorders</condition>
    <condition>Personality Disorders and Disturbances in Behavior</condition>
    <condition>Personality Disorders, Antisocial</condition>
    <condition>Intellectual Disability, Mild to Moderate</condition>
    <arm_group>
      <arm_group_label>Therapeutic security</arm_group_label>
      <description>assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Risk Measures of Need (RISKMON)</arm_group_label>
      <description>assessed symptom severity, risk and protective factors for violence, global function, personality factors.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment as usual (TAU)</intervention_name>
      <description>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.</description>
      <arm_group_label>Risk Measures of Need (RISKMON)</arm_group_label>
      <arm_group_label>Therapeutic security</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Residents admitted to Residences for the Execution of Security Measures (REMS) under court&#xD;
          orders: found by the court to be partially responsible (Penal Code 89) or completely not&#xD;
          criminally responsible (Penal Code 88) for a crime and also found socially dangerous (Penal&#xD;
          Code 203).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  admitted to REMS&#xD;
  &#xD;
            -  voluntarily consents to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  MMSE less than 19&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Felice F Carabellese, MD</last_name>
      <role>Study Director</role>
      <affiliation>University of Bari</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lia Parente, PsyD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Bari</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Harry G Kennedy, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Dublin Trinity College (TCD)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mary Davoren, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Dublin Trinity College (TCD)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Bari</name>
        <address>
          <city>Bari</city>
          <zip>70124</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>35861358</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>21410967</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31122631</PMID>
    </reference>
    <reference>
      <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</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27766115</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32482202</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27256003</PMID>
    </reference>
    <reference>
      <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.</citation>
    </reference>
    <reference>
      <citation>Cura e controllo. Come cambia la pericolosità sociale psichiatrica R Catanesi, FF Carabellese, I Grattagliano - Giornale Italiano di Psicopatologia, 2009</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30026395</PMID>
    </reference>
    <reference>
      <citation>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</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32141478</PMID>
    </reference>
    <reference>
      <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</citation>
    </reference>
    <reference>
      <citation>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</citation>
    </reference>
    <reference>
      <citation>Models of care in forensic psychiatry HG Kennedy - BJPsych Advances, 2022</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Bari</investigator_affiliation>
      <investigator_full_name>Felice Carabellese</investigator_full_name>
      <investigator_title>Full Professor of Forensic Psychopathology</investigator_title>
    </responsible_party>
    <keyword>Forensic</keyword>
    <keyword>social dangerousness</keyword>
    <keyword>therapeutic security</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intellectual Disability</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Personality Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Antisocial Personality Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>In view of the sensitive nature of the data, aggregated anonymised data may be provided to accredited researchers on a case by case basis.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018298
  org study id: ITAL-EE-REMS
  nct id: NCT06018298
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: length of stay in REMS
  time frame: date of admission to REMS through study completion, an average of 18 months
  description: time (days) from admission to move out of REMS
  measure: Functional recovery
  time frame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
  description: change in GAF over time
  measure: violence while in REMS
  time frame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
  description: MOAS in the intervals between first, second and third assessments in REMS an average of 18 months
  measure: Readmission to REMS
  time frame: date of discharge from REMS to date of readmission to REMS, if any.
  description: time (days) until readmission to REMS following discharge from REMS an average of 18 months
  measure: conditional discharge
  time frame: date of assessment to date of conditional discharge an average of 18 months
  description: time (days) from date of assessment to date of conditional discharge
  measure: Death
  time frame: from date of admission to date of death while in REMS, if any up to two years
  description: death while in REMS, if any
  arm group label: Therapeutic security
  description: assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery.
  arm group label: Risk Measures of Need (RISKMON)
  description: assessed symptom severity, risk and protective factors for violence, global function, personality factors.
  intervention type: Other
  intervention name: Treatment as usual (TAU)
  description: 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 group label: Risk Measures of Need (RISKMON)
  arm group label: Therapeutic security
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Felice F Carabellese, MD
  role: Study Director
  affiliation: University of Bari
  last name: Lia Parente, PsyD
  role: Principal Investigator
  affiliation: University of Bari
  last name: Harry G Kennedy, MD
  role: Principal Investigator
  affiliation: University of Dublin Trinity College (TCD)
  last name: Mary Davoren, MD
  role: Principal Investigator
  affiliation: University of Dublin Trinity College (TCD)
  facility: 
  country: Italy
  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.
  PMID: 35861358
  citation: 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.
  PMID: 21410967
  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.
  PMID: 31122631
  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
  citation: 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.
  PMID: 27766115
  citation: 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.
  PMID: 32482202
  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.
  PMID: 27256003
  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.
  citation: Cura e controllo. Come cambia la pericolosità sociale psichiatrica R Catanesi, FF Carabellese, I Grattagliano - Giornale Italiano di Psicopatologia, 2009
  citation: 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.
  PMID: 30026395
  citation: 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
  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.
  PMID: 32141478
  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
  citation: 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
  citation: Models of care in forensic psychiatry HG Kennedy - BJPsych Advances, 2022
  responsible party type: Principal Investigator
  investigator affiliation: University of Bari
  investigator full name: Felice Carabellese
  investigator title: Full Professor of Forensic Psychopathology
  mesh term: Intellectual Disability
  mesh term: Schizophrenia
  mesh term: Personality Disorders
  mesh term: Mental Disorders
  mesh term: Antisocial Personality Disorder
  sharing ipd: No
  ipd description: In view of the sensitive nature of the data, aggregated anonymised data may be provided to accredited researchers on a case by case basis.