<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/NCT03273530</url>
  </required_header>
  <id_info>
    <org_study_id>201415</org_study_id>
    <nct_id>NCT03273530</nct_id>
  </id_info>
  <brief_title>Integrated Supported Employment in Mainland China</brief_title>
  <official_title>Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized controlled trial, the researchers investigated the effectiveness of&#xD;
      integrated supported employment (ISE) as compared with individual placement and support (IPS)&#xD;
      and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland&#xD;
      China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n =&#xD;
      54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure,&#xD;
      and psychological outcomes were conducted at admission, completion of the 3-mo program, and&#xD;
      follow-up at 7, 11, and 15 mo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">December 20, 2015</completion_date>
  <primary_completion_date type="Actual">August 15, 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Employment rate</measure>
    <time_frame>4 months</time_frame>
    <description>employment status, employed or unemployed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Job tenure, duration</measure>
    <time_frame>completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.</time_frame>
    <description>how long the job lasts</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Integrated Supported Employment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual placement support intervention plus work-related social skills training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individualised Placement Support</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Vocational Rehabilitation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>general pre-vocational training and placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integrated Supported Employment</intervention_name>
    <description>vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement</description>
    <arm_group_label>Integrated Supported Employment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older;&#xD;
&#xD;
          -  Diagnosis of schizophrenia for at least 2 years&#xD;
&#xD;
          -  Being unemployed&#xD;
&#xD;
          -  Willing to give informed consent&#xD;
&#xD;
          -  Having no obvious cognitive, learning, or neurological impairment&#xD;
&#xD;
          -  Having completed primary school education&#xD;
&#xD;
          -  Having a desire to work&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Having score lower than 18 on the 30-item Mini-Mental State Examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hector WH Tsang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HKPolyU</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>TSANG Hector Wing-Hong</investigator_full_name>
    <investigator_title>Professor and Department Head of Rehabilitation Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not yet decided</ipd_description>
  </patient_data>
  <!-- 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/NCT03273530
org study id: 201415
nct id: NCT03273530
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this randomized controlled trial, the researchers investigated the effectiveness of
      integrated supported employment (ISE) as compared with individual placement and support (IPS)
      and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland
      China.
One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n =
      54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure,
      and psychological outcomes were conducted at admission, completion of the 3-mo program, and
      follow-up at 7, 11, and 15 mo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Employment rate
time frame: 4 months
description: employment status, employed or unemployed
measure: Job tenure, duration
time frame: completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
description: how long the job lasts
arm group label: Integrated Supported Employment
arm group type: Experimental
description: Individual placement support intervention plus work-related social skills training
arm group label: Individualised Placement Support
arm group type: No Intervention
description: Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities
arm group label: Traditional Vocational Rehabilitation
arm group type: No Intervention
description: general pre-vocational training and placement
intervention type: Other
intervention name: Integrated Supported Employment
description: vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
arm group label: Integrated Supported Employment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hector WH Tsang, PhD
role: Principal Investigator
affiliation: HKPolyU
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: TSANG Hector Wing-Hong
investigator title: Professor and Department Head of Rehabilitation Sciences
mesh term: Schizophrenia
sharing ipd: Undecided
ipd description: Not yet decided