<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/NCT03043417</url>
  </required_header>
  <id_info>
    <org_study_id>0512014</org_study_id>
    <nct_id>NCT03043417</nct_id>
  </id_info>
  <brief_title>Stigma Intervention Among Primary Health Workers in Toronto</brief_title>
  <official_title>Exploring Stigma, Discrimination, and Recovery-based Perspectives Toward Mental Illness and Substance Use Problems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is measuring the effectiveness of an anti-stigma intervention among primary care&#xD;
      providers. Both staff and clients will be asked to complete survey data in order to measure&#xD;
      the effectiveness. This is a randomized control trial in that three health centres will&#xD;
      receive the intervention and three will not. Results will determine if this intervention&#xD;
      reduces stigma among staff toward people with a mental health problem and/or substance use&#xD;
      problem.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Office of Transformative Global Health at the Centre for Addiction and Mental Health&#xD;
      (CAMH), with funding provided by the Canadian Institutes of Health Research (CIHR), has&#xD;
      developed and will be implementing a three year anti-stigma study. This project is a&#xD;
      randomized control study which compares the effectiveness of an anti-stigma intervention in&#xD;
      three Toronto community health centres. Six centres were selected and randomized so that&#xD;
      three receive the intervention and the other three do not. The goal is to determine if the&#xD;
      intervention impacts service providers' attitudes and behaviours towards people with mental&#xD;
      health problems and addictions. Additionally, the study measures client's perceptions of&#xD;
      stigma in order to see if they believe stigma has been reduced or eliminated. The&#xD;
      interventions incorporate the following components: innovative contact-based training,&#xD;
      raising awareness, recovery-based arts, and a thorough analysis of each centre's policies and&#xD;
      procedures.&#xD;
&#xD;
      Innovative contact-based training utilizes an adult education model and focuses on the&#xD;
      results of a preliminary situational assessment conducted at each site. Emphasis is placed on&#xD;
      concurrent disorders, cultural issues, and inter-professional collaboration. Four three-hour&#xD;
      workshops were held at each intervention CHC throughout the project period and included a&#xD;
      needs-based curriculum, contact-based education to reduce prejudice and social intolerance,&#xD;
      and culturally competent care for vulnerable populations. Raising awareness includes various&#xD;
      forms of media such as posters to increase awareness about stigma.&#xD;
&#xD;
      Recovery-based arts was geared towards a local team of leaders who selected one art form for&#xD;
      their CHC and were taught by an art expert. Approximately ten service users with a mental&#xD;
      health and/or substance abuse problem were invited to participate along with three staff&#xD;
      members. After 10 bi-weekly art workshops, staff and clients will showcase their work at each&#xD;
      CHC. Finally, an analysis of policies and procedures have been conducted by research staff.&#xD;
      This determines what already exists and using an anti-stigma/pro-recovery approach to&#xD;
      identify strengths and areas for improvement. Program and policies were studied to identify&#xD;
      unintended positive and negative impacts using a modified version of the Health Equity&#xD;
      Assessment Tool. Features of the Quality Rights Tool Kit were also used. Recommendations from&#xD;
      this process will be developed and shared with each CHC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opening Minds Scale for Health Care Providers (OMS-HC)</measure>
    <time_frame>2 years</time_frame>
    <description>The OMS-HC is a 20-item Canadian scale that was developed specifically to measure stigma among healthcare providers toward individuals with mental illness.This scale has good internal consistency (Cronbach's alpha = 0.82), satisfactory test-retest reliability, intra-class correlation (0.66; 95% CI: 0.54-0.75)59 and sensitivity to change.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Illness: Clinicians Attitudes Scale (MICA)</measure>
    <time_frame>2 years</time_frame>
    <description>MICA is a 16-item scale that was also designed to measure attitudes among healthcare workers toward individuals with mental illness.The MICA scale has good internal consistency (Cronbach's alpha = 0.79), with a test-retest reliability (concordance) of 0.80 (95% CI: 0.68-0.91).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Borgadus Social Distance Scale</measure>
    <time_frame>2 years</time_frame>
    <description>The Modified Borgadus Social Distance Scale is based on the Borgadus Social Distance Scale.Our study will use a modified six-item version of this scale, focusing specifically on persons with one key mental illness (schizophrenia) and one key addiction (heroin dependence).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Mental Health Disorder</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>CHC's given the intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three CHC sites where all staff receive all components of the intervention. Training, Media, Art workshops, and a Policy analysis as well as survey completion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHC's with NO intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Three CHC sites where all staff and a selection of clients complete surveys but receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHC's given the intervention</intervention_name>
    <description>CHC's NOT given the intervention</description>
    <arm_group_label>CHC's given the intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Staff - all staff, no matter their position, is asked to participate.&#xD;
&#xD;
          -  Clients - individuals reporting current or past mental illness and/or substance use&#xD;
             problems (MHSUD) AND have received services or participate in any programming at the&#xD;
             CHC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Staff - no exclusion criteria&#xD;
&#xD;
          -  Clients - Clients under the age of 18 years, clients who do not have a MHSUD, or&#xD;
             clients that are not safely able to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akwatu A Khenti, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2N5E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.net/research</url>
    <description>Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>July 4, 2017</last_update_submitted>
  <last_update_submitted_qc>July 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Akwatu Khenti</investigator_full_name>
    <investigator_title>Director, Global Health</investigator_title>
  </responsible_party>
  <keyword>Stigma</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03043417
org study id: 0512014
nct id: NCT03043417
lead sponsor: 
collaborator: 
has dmc: No
This project is measuring the effectiveness of an anti-stigma intervention among primary care
      providers. Both staff and clients will be asked to complete survey data in order to measure
      the effectiveness. This is a randomized control trial in that three health centres will
      receive the intervention and three will not. Results will determine if this intervention
      reduces stigma among staff toward people with a mental health problem and/or substance use
      problem.
The Office of Transformative Global Health at the Centre for Addiction and Mental Health
      (CAMH), with funding provided by the Canadian Institutes of Health Research (CIHR), has
      developed and will be implementing a three year anti-stigma study. This project is a
      randomized control study which compares the effectiveness of an anti-stigma intervention in
      three Toronto community health centres. Six centres were selected and randomized so that
      three receive the intervention and the other three do not. The goal is to determine if the
      intervention impacts service providers' attitudes and behaviours towards people with mental
      health problems and addictions. Additionally, the study measures client's perceptions of
      stigma in order to see if they believe stigma has been reduced or eliminated. The
      interventions incorporate the following components: innovative contact-based training,
      raising awareness, recovery-based arts, and a thorough analysis of each centre's policies and
      procedures.

      Innovative contact-based training utilizes an adult education model and focuses on the
      results of a preliminary situational assessment conducted at each site. Emphasis is placed on
      concurrent disorders, cultural issues, and inter-professional collaboration. Four three-hour
      workshops were held at each intervention CHC throughout the project period and included a
      needs-based curriculum, contact-based education to reduce prejudice and social intolerance,
      and culturally competent care for vulnerable populations. Raising awareness includes various
      forms of media such as posters to increase awareness about stigma.

      Recovery-based arts was geared towards a local team of leaders who selected one art form for
      their CHC and were taught by an art expert. Approximately ten service users with a mental
      health and/or substance abuse problem were invited to participate along with three staff
      members. After 10 bi-weekly art workshops, staff and clients will showcase their work at each
      CHC. Finally, an analysis of policies and procedures have been conducted by research staff.
      This determines what already exists and using an anti-stigma/pro-recovery approach to
      identify strengths and areas for improvement. Program and policies were studied to identify
      unintended positive and negative impacts using a modified version of the Health Equity
      Assessment Tool. Features of the Quality Rights Tool Kit were also used. Recommendations from
      this process will be developed and shared with each CHC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Opening Minds Scale for Health Care Providers (OMS-HC)
time frame: 2 years
description: The OMS-HC is a 20-item Canadian scale that was developed specifically to measure stigma among healthcare providers toward individuals with mental illness.This scale has good internal consistency (Cronbach's alpha = 0.82), satisfactory test-retest reliability, intra-class correlation (0.66; 95% CI: 0.54-0.75)59 and sensitivity to change.
measure: Mental Illness: Clinicians Attitudes Scale (MICA)
time frame: 2 years
description: MICA is a 16-item scale that was also designed to measure attitudes among healthcare workers toward individuals with mental illness.The MICA scale has good internal consistency (Cronbach's alpha = 0.79), with a test-retest reliability (concordance) of 0.80 (95% CI: 0.68-0.91).
measure: Modified Borgadus Social Distance Scale
time frame: 2 years
description: The Modified Borgadus Social Distance Scale is based on the Borgadus Social Distance Scale.Our study will use a modified six-item version of this scale, focusing specifically on persons with one key mental illness (schizophrenia) and one key addiction (heroin dependence).
arm group label: CHC's given the intervention
arm group type: Experimental
description: Three CHC sites where all staff receive all components of the intervention. Training, Media, Art workshops, and a Policy analysis as well as survey completion.
arm group label: CHC's with NO intervention
arm group type: No Intervention
description: Three CHC sites where all staff and a selection of clients complete surveys but receive no intervention.
intervention type: Behavioral
intervention name: CHC's given the intervention
description: CHC's NOT given the intervention
arm group label: CHC's given the intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Akwatu A Khenti, MA
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.net/research
description: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Akwatu Khenti
investigator title: Director, Global Health
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
sharing ipd: No