<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/NCT01722344</url>
  </required_header>
  <id_info>
    <org_study_id>PCK-2012-CT-2912</org_study_id>
    <nct_id>NCT01722344</nct_id>
  </id_info>
  <brief_title>Improving Work Outcome for People With Severe Mental Illness</brief_title>
  <official_title>Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mental Health Centre Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen Municipality, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense Municipality</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen Trial Unit, Center for Clinical Intervention Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Silkeborg Municipality</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mental Health Centre Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of IPS in Denmark and compare&#xD;
      effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and&#xD;
      work-related social skills training vs. 3. standard intervention, among individuals with&#xD;
      severe mental illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individual Placement and Support (IPS) is established as the most effective vocational&#xD;
      intervention available for persons with severe mental illness,and the intervention is widely&#xD;
      recognized as an evidence-based practice. Despite evidence, long-term job retention and&#xD;
      economic self-sufficiency have not been clearly demonstrated. Research has suggested that&#xD;
      integrating methods such as cognitive remediation and social skills training could reduce&#xD;
      such limitations. Further, there has not been conducted any randomized controled trials with&#xD;
      IPS in Scandinavian countries with highly developed and generous social security and welfare&#xD;
      systems, and with high thresholds to the open labour market.&#xD;
&#xD;
      The aim of this study is to investigate the effectiveness of IPS in Denmark and compare&#xD;
      effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training&#xD;
      vs. 3. Standard intervention.&#xD;
&#xD;
      The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced&#xD;
      with cognitive remediation and work-related social skills training, consists of 24 sessions&#xD;
      of computer based cognitive training and 24 group based sessions of cognitive coping&#xD;
      strategies and work-related social skills training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hours in competitive employment or education</measure>
    <time_frame>Measured at 18 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>In competitive employment or education at some point during follow up period</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to first employment or beginning of education</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average monthly earnings in follow-up period</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hours of work per week among those who obtain competitive employment during the follow-up period</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functioning measured with Global Assessment of Functioning (GAF)</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functioning measured with Personal and Social Performance (PSP)</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured with SF-12</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment measured with Empowerment Scale</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy measured with General self-efficacy scale (GSE)</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem measured with The Rosenberg Self-Esteem scale</measure>
    <time_frame>Measured at 18 month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">717</enrollment>
  <condition>Schizophrenia, Schizotypal and Delusional Disorders</condition>
  <condition>Bipolar Affective Disorder</condition>
  <condition>Recurrent Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Individual Placement and Support (IPS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IPS plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual Placement and Support plus cognitive remediation and work-related social skills training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual Placement and support (IPS)</intervention_name>
    <description>IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling</description>
    <arm_group_label>IPS plus</arm_group_label>
    <arm_group_label>Individual Placement and Support (IPS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IPS plus</intervention_name>
    <description>Individual Placement and Support + cognitive remediation and work-related social skills training, consists of the IPS intervention + 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.</description>
    <arm_group_label>IPS plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Psychosis within the schizophrenic spectrum (F 2, International Classification of Diseases&#xD;
        (ICD 10)).&#xD;
&#xD;
        Severe depression (F33, ICD-10) or Bipolar disorder (F31, ICD-10) and minimum 3 years&#xD;
        psychiatric treatment.&#xD;
&#xD;
        Motivated for employment or education. 18 to 65 years old. Participants must speak and&#xD;
        understand Danish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Lack of informed consent Above 64 years and receiving state pension Match group 1 (No&#xD;
        problems besides unemployment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lene F Eplov, MD, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Copenhagen University Hospital, Mental Health Centre Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Merete Nordentoft, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Copenhagen University Hospital, Mental Health Centre Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elsebeth Stenager, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, Odense, The University of Southern Denmark.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bent Nielsen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, Odense, The University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Centre Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe mental illness</keyword>
  <keyword>Vocational rehabilitation</keyword>
  <keyword>Supported employment</keyword>
  <keyword>Individual placement and support</keyword>
  <keyword>Cognitive remediation</keyword>
  <keyword>Social skill training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Schizophrenia, Paranoid</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01722344
org study id: PCK-2012-CT-2912
nct id: NCT01722344
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate the efficacy of IPS in Denmark and compare
      effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and
      work-related social skills training vs. 3. standard intervention, among individuals with
      severe mental illness.
Individual Placement and Support (IPS) is established as the most effective vocational
      intervention available for persons with severe mental illness,and the intervention is widely
      recognized as an evidence-based practice. Despite evidence, long-term job retention and
      economic self-sufficiency have not been clearly demonstrated. Research has suggested that
      integrating methods such as cognitive remediation and social skills training could reduce
      such limitations. Further, there has not been conducted any randomized controled trials with
      IPS in Scandinavian countries with highly developed and generous social security and welfare
      systems, and with high thresholds to the open labour market.

      The aim of this study is to investigate the effectiveness of IPS in Denmark and compare
      effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training
      vs. 3. Standard intervention.

      The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced
      with cognitive remediation and work-related social skills training, consists of 24 sessions
      of computer based cognitive training and 24 group based sessions of cognitive coping
      strategies and work-related social skills training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Hours in competitive employment or education
time frame: Measured at 18 month
measure: In competitive employment or education at some point during follow up period
time frame: Measured at 18 month follow-up
measure: Days to first employment or beginning of education
time frame: Measured at 18 month follow-up
measure: Average monthly earnings in follow-up period
time frame: Measured at 18 month follow-up
measure: Hours of work per week among those who obtain competitive employment during the follow-up period
time frame: Measured at 18 month follow-up
measure: Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
time frame: Measured at 18 month follow-up
measure: Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
time frame: Measured at 18 month follow-up
measure: Functioning measured with Global Assessment of Functioning (GAF)
time frame: Measured at 18 month follow-up
measure: Functioning measured with Personal and Social Performance (PSP)
time frame: Measured at 18 month follow-up
measure: Quality of life measured with SF-12
time frame: Measured at 18 month follow-up
measure: Empowerment measured with Empowerment Scale
time frame: Measured at 18 month follow-up
measure: Self-efficacy measured with General self-efficacy scale (GSE)
time frame: Measured at 18 month follow-up
measure: Self-esteem measured with The Rosenberg Self-Esteem scale
time frame: Measured at 18 month follow-up
arm group label: Individual Placement and Support (IPS)
arm group type: Experimental
arm group label: IPS plus
arm group type: Experimental
description: Individual Placement and Support plus cognitive remediation and work-related social skills training
arm group label: Standard intervention
arm group type: No Intervention
intervention type: Behavioral
intervention name: Individual Placement and support (IPS)
description: IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling
arm group label: IPS plus
arm group label: Individual Placement and Support (IPS)
intervention type: Behavioral
intervention name: IPS plus
description: Individual Placement and Support + cognitive remediation and work-related social skills training, consists of the IPS intervention + 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
arm group label: IPS plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Lene F Eplov, MD, Phd
role: Study Director
affiliation: Copenhagen University Hospital, Mental Health Centre Copenhagen
last name: Merete Nordentoft, Professor
role: Principal Investigator
affiliation: Copenhagen University Hospital, Mental Health Centre Copenhagen
last name: Elsebeth Stenager, MD, Phd
role: Principal Investigator
affiliation: Department of Psychiatry, Odense, The University of Southern Denmark.
last name: Bent Nielsen, Professor
role: Principal Investigator
affiliation: Department of Psychiatry, Odense, The University of Southern Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Depressive Disorder
mesh term: Mood Disorders
mesh term: Bipolar Disorder
mesh term: Schizophrenia, Paranoid