<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/NCT04448704</url>
  </required_header>
  <id_info>
    <org_study_id>CCF@EXPO/R001/2020</org_study_id>
    <nct_id>NCT04448704</nct_id>
  </id_info>
  <brief_title>Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak</brief_title>
  <official_title>Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale-NUS College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale-NUS College</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>
      This study aims to evaluate the mental health impact of the COVID-19 pandemic on&#xD;
      international migrant workers by (1) documenting mental health symptoms among migrant workers&#xD;
      and (2) identifying risk and protective factors during the pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide, there are an estimated 164 million migrant workers. Although studies have&#xD;
      documented how migrant workers have an increased risk of adverse mental health outcomes,&#xD;
      little is known about their mental health burden during a large-scale health crisis.&#xD;
&#xD;
      In the current COVID-19 outbreak, migrant workers represent 9 in 10 of the COVID-19 cases in&#xD;
      Singapore, with 25 dormitories gazetted to contain the spread of the virus. Correspondingly,&#xD;
      these measures have placed a spotlight on the mental well-being of migrant workers.&#xD;
&#xD;
      In this research protocol, the investigators propose to administer a survey to understand the&#xD;
      prevalence and predictors of mental health symptoms amongst migrant workers in Singapore. In&#xD;
      particular, prior meta-analyses have identified COVID-19 health concerns, quarantine status,&#xD;
      financial instability, exposure to news and misinformation and demographics (i.e., gender,&#xD;
      age, education) as risk factors for poor mental health amongst the general population. By&#xD;
      assessing these factors amongst the migrant worker population and documenting their impact on&#xD;
      migrant workers' mental health, we hope to identify workers in greatest need of support&#xD;
      during the ongoing pandemic and provide empirical evidence to guide public health policies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">October 11, 2020</completion_date>
  <primary_completion_date type="Actual">October 11, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DASS-21 Scores</measure>
    <time_frame>single measurement upon study enrolment</time_frame>
    <description>Depression, Anxiety and Stress Scale (DASS-21) is a validated 21-item measure that has been widely used during the current COVID-19 pandemic.</description>
  </primary_outcome>
  <enrollment type="Actual">1011</enrollment>
  <condition>Mental Health Issue</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Migrant workers employed in manual labor jobs within Singapore&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥21 years of age&#xD;
&#xD;
          -  Hold a government-issued work permit identifying employment status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EXPO</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04448704
org study id: CCF@EXPO/R001/2020
nct id: NCT04448704
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the mental health impact of the COVID-19 pandemic on
      international migrant workers by (1) documenting mental health symptoms among migrant workers
      and (2) identifying risk and protective factors during the pandemic.
Worldwide, there are an estimated 164 million migrant workers. Although studies have
      documented how migrant workers have an increased risk of adverse mental health outcomes,
      little is known about their mental health burden during a large-scale health crisis.

      In the current COVID-19 outbreak, migrant workers represent 9 in 10 of the COVID-19 cases in
      Singapore, with 25 dormitories gazetted to contain the spread of the virus. Correspondingly,
      these measures have placed a spotlight on the mental well-being of migrant workers.

      In this research protocol, the investigators propose to administer a survey to understand the
      prevalence and predictors of mental health symptoms amongst migrant workers in Singapore. In
      particular, prior meta-analyses have identified COVID-19 health concerns, quarantine status,
      financial instability, exposure to news and misinformation and demographics (i.e., gender,
      age, education) as risk factors for poor mental health amongst the general population. By
      assessing these factors amongst the migrant worker population and documenting their impact on
      migrant workers' mental health, we hope to identify workers in greatest need of support
      during the ongoing pandemic and provide empirical evidence to guide public health policies.
observational model: Cohort
time perspective: Cross-Sectional
measure: DASS-21 Scores
time frame: single measurement upon study enrolment
description: Depression, Anxiety and Stress Scale (DASS-21) is a validated 21-item measure that has been widely used during the current COVID-19 pandemic.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Sponsor
sharing ipd: No