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/NCT05982548</url>
    </required_header>
    <id_info>
      <org_study_id>2023/00027</org_study_id>
      <nct_id>NCT05982548</nct_id>
    </id_info>
    <brief_title>The Use of a Virtual Reality Intervention on Stigma, Empathy and Attitudes Towards People With Psychotic Disorders</brief_title>
    <official_title>The Use of a Virtual Reality Intervention on Stigma, Empathy and Attitudes Towards People With Psychotic Disorders Among Mental Healthcare Professionals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Mental Health, Singapore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Mental Health, Singapore</source>
    <oversight_info>
      <has_dmc>No</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 goal of this clinical trial is to evaluate the effectiveness of a VR intervention on (1)&#xD;
        stigma, (2) empathy and (3) attitudes towards those experiencing mental disorders.&#xD;
  &#xD;
        Participants will review a VR intervention, and complete questionnaires at pre-test,&#xD;
        post-test and one month follow-up.&#xD;
  &#xD;
        Researchers will compare the VR intervention with a control VR intervention to evaluate the&#xD;
        varying effects on stigma, empathy and attitudes towards those experiencing mental disorders.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 17, 2024</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Desire for Social Distance</measure>
      <time_frame>pre-intervention, immediately after the intervention, follow-up at 1 month after intervention</time_frame>
      <description>Desire for Social Distance Scale&#xD;
  The eight questions are rated on a four-point Likert scale:&#xD;
  yes, definitely (0), yes, probably (1), probably not (2) and definitely not (3) with greater scores implying greater desire for social distancing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Personal Stigma</measure>
      <time_frame>pre-intervention, immediately after the intervention, follow-up at 1 month after intervention</time_frame>
      <description>Personal Stigma Scale Personal Stigma Scale consisted of two subscales: 'Personal unpredictable/ dangerousness' and 'Personal weak not sick' The questions were calculated as 'strongly agree' (4) to 'strongly disagree' (0), with greater scores implying greater stigmatizing attitudes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Empathy</measure>
      <time_frame>pre-intervention, immediately after the intervention, follow-up at 1 month after intervention</time_frame>
      <description>Empathetic concern sub-scale of Interpersonal Reactivity Index The 7-item sub-scale is measured on a five point likert scale ranging from 'does not describe me well' (0) to 'describes me very well' (4).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attitudes towards those experiencing mental disorders</measure>
      <time_frame>pre-intervention, immediately after the intervention, follow-up at 1 month after intervention</time_frame>
      <description>modified Attitudes Towards People with Schizophrenia scale The 7-item scale is measured on a nine point likert scale ranging from (1) to (9). Greater scores equate better attitude towards people with schizophrenia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic data</measure>
      <time_frame>pre-intervention</time_frame>
      <description>occupation, gender, marital status, ethnic groups, age, years of service</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>Authors constructed questionnaire to assess for acceptability of intervention. A total of 10 questions consisting of 6 multiple choice questions ranging from strongly disagree to strongly agree on a 7-point likert scale. An example of one question is, 'I find the intervention engaging'.&#xD;
  It also consists of 4 open ended questions. Example of one question is, 'Please list the strength of the intervention'</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of VR intervention</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>Visually induced motion sickness susceptibility questionnaire:&#xD;
  It consists of six questions that evaluates presence of adverse effects from using the VR intervention from 'never' (0) to 'often' (3).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Mental Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The VR intervention was created using the Unreal Engine software (Unreal Engine, 2022). The VR intervention includes the scenario of a home.&#xD;
  Participants will view the home as a first person character and experience psychotic phenomena including auditory hallucinations. The intervention will be delivered in one setting and lasts no more than seven minutes. It will be disseminated using smartphone inserted into VR headset equivalent of google cardboard.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>VR control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The VR control group will view the scenario of the same home without the simulated visual and auditory hallucinations.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>VR intervention</intervention_name>
      <description>VR intervention of no more than 7 minutes&#xD;
  Participants viewed the home as a first person character and experience psychotic phenomena including auditory hallucinations.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>VR control intervention</intervention_name>
      <description>VR intervention of no more than 7 minutes&#xD;
  Participants viewed the same home as a first person character without psychotic phenomena</description>
      <arm_group_label>VR control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who are aged at least 21 years old&#xD;
  &#xD;
            -  Employed by the Institute of Mental Health as a physician, allied health professional&#xD;
               or nurse.&#xD;
  &#xD;
            -  understands English&#xD;
  &#xD;
            -  work directly with patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to use virtual reality interventions due to reasons including motion sickness,&#xD;
               disorientation, nausea and vomiting.&#xD;
  &#xD;
            -  history of epilepsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Institute of Mental Health</name>
        <address>
          <city>Singapore</city>
          <zip>539747</zip>
          <country>Singapore</country>
        </address>
      </facility>
      <contact>
        <last_name>Jing Ling Tay, PhD</last_name>
        <phone>6389</phone>
        <phone_ext>2337</phone_ext>
        <email>jing_ling_tay@imh.com.sg</email>
      </contact>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute of Mental Health, Singapore</investigator_affiliation>
      <investigator_full_name>Tay Jing Ling</investigator_full_name>
      <investigator_title>Advanced Practice Nurse</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic 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>
  
  
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/NCT05982548
  org study id: 2023/00027
  nct id: NCT05982548
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the effectiveness of a VR intervention on (1)
        stigma, (2) empathy and (3) attitudes towards those experiencing mental disorders.
  
        Participants will review a VR intervention, and complete questionnaires at pre-test,
        post-test and one month follow-up.
  
        Researchers will compare the VR intervention with a control VR intervention to evaluate the
        varying effects on stigma, empathy and attitudes towards those experiencing mental disorders.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Desire for Social Distance
  time frame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
  description: Desire for Social Distance Scale
  The eight questions are rated on a four-point Likert scale:
  yes, definitely (0), yes, probably (1), probably not (2) and definitely not (3) with greater scores implying greater desire for social distancing.
  measure: Personal Stigma
  time frame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
  description: Personal Stigma Scale Personal Stigma Scale consisted of two subscales: 'Personal unpredictable/ dangerousness' and 'Personal weak not sick' The questions were calculated as 'strongly agree' (4) to 'strongly disagree' (0), with greater scores implying greater stigmatizing attitudes.
  measure: Empathy
  time frame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
  description: Empathetic concern sub-scale of Interpersonal Reactivity Index The 7-item sub-scale is measured on a five point likert scale ranging from 'does not describe me well' (0) to 'describes me very well' (4).
  measure: Attitudes towards those experiencing mental disorders
  time frame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
  description: modified Attitudes Towards People with Schizophrenia scale The 7-item scale is measured on a nine point likert scale ranging from (1) to (9). Greater scores equate better attitude towards people with schizophrenia.
  measure: Demographic data
  time frame: pre-intervention
  description: occupation, gender, marital status, ethnic groups, age, years of service
  measure: Acceptability of the intervention
  time frame: immediately after the intervention
  description: Authors constructed questionnaire to assess for acceptability of intervention. A total of 10 questions consisting of 6 multiple choice questions ranging from strongly disagree to strongly agree on a 7-point likert scale. An example of one question is, 'I find the intervention engaging'.
  It also consists of 4 open ended questions. Example of one question is, 'Please list the strength of the intervention'
  measure: Safety of VR intervention
  time frame: immediately after the intervention
  description: Visually induced motion sickness susceptibility questionnaire:
  It consists of six questions that evaluates presence of adverse effects from using the VR intervention from 'never' (0) to 'often' (3).
  arm group label: Intervention group
  arm group type: Experimental
  description: The VR intervention was created using the Unreal Engine software (Unreal Engine, 2022). The VR intervention includes the scenario of a home.
  Participants will view the home as a first person character and experience psychotic phenomena including auditory hallucinations. The intervention will be delivered in one setting and lasts no more than seven minutes. It will be disseminated using smartphone inserted into VR headset equivalent of google cardboard.
  arm group label: VR control group
  arm group type: Active Comparator
  description: The VR control group will view the scenario of the same home without the simulated visual and auditory hallucinations.
  intervention type: Other
  intervention name: VR intervention
  description: VR intervention of no more than 7 minutes
  Participants viewed the home as a first person character and experience psychotic phenomena including auditory hallucinations.
  arm group label: Intervention group
  intervention type: Other
  intervention name: VR control intervention
  description: VR intervention of no more than 7 minutes
  Participants viewed the same home as a first person character without psychotic phenomena
  arm group label: VR control group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  country: Singapore
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Mental Health, Singapore
  investigator full name: Tay Jing Ling
  investigator title: Advanced Practice Nurse
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  sharing ipd: No