<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/NCT04497636</url>
  </required_header>
  <id_info>
    <org_study_id>170519004</org_study_id>
    <nct_id>NCT04497636</nct_id>
  </id_info>
  <brief_title>Mental Health Impact of the COVID-19 Pandemic Among Migrants in Chile</brief_title>
  <acronym>STRING-COVID</acronym>
  <official_title>Mental Health Impact of the COVID-19 Pandemic Among Immigrants in Santiago, Chile (STRING-COVID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondo Nacional de Desarrollo Científico y Tecnológico, Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</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>
      The mental health of a representative sample of immigrants residing in Santiago, Chile&#xD;
      (STRING cohort) was assessed nine months prior to the COVID-19 pandemic (T0). Evidence&#xD;
      suggests that social isolation affects mental health by increasing symptoms of anxiety and&#xD;
      depression. One of the main components of the current COVID-19 pandemic is the social&#xD;
      isolation imposed on the population. This study seeks to explore the short (T1) and long-term&#xD;
      (T2) effects of the pandemic on the psychological wellbeing of the cohort.&#xD;
&#xD;
      Specific aims are to&#xD;
&#xD;
        1. Describe the variations in the levels of mental health problems (i.e. symptoms of&#xD;
           depression, anxiety, post-traumatic stress, sleep difficulties) and wellbeing of&#xD;
           immigrants during the first (T1) and second follow-up (T2)&#xD;
&#xD;
        2. Calculate the short (T1) and long-term (T2) effects of social isolation on the levels of&#xD;
           mental health problems of the immigrant population, and&#xD;
&#xD;
        3. Identify risk / protective factors associated with a short (T1) and long-term (T2)&#xD;
           increase in mental health problems&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were interviewed at baseline (T0) 8 months before the COVID-19 pandemic. An&#xD;
      online survey will be applied in two follow-up moments during the pandemic:&#xD;
&#xD;
        1. At 9 months (also 1 month after lockdown measures imposed) (T1)&#xD;
&#xD;
        2. At 18 months (also 10 months after lockdown measures imposed) (T2)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">April 18, 2021</completion_date>
  <primary_completion_date type="Actual">April 18, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer &amp; Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicate that the patient is within the depressive area. Specific cut-off for primary care samples in Chile have been found yielding a cut-off of 7 and above for high sensitivity and specificity (Saldivia, Aslan, Cova, Vicente, Inostroza &amp; Rincón, 2019).&#xD;
Changes in depressive symptoms between baseline (T0) and two follow-up points (T1 and T2) will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms of anxiety</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams &amp; Löwe, 2006) is used to measure symptoms of anxiety and worry. The questionnaire consists of seven items scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for primary care samples in Spain have been found yielding a cut-off of 10 and above for high sensitivity and specificity (García-Campayo et al, 2010).&#xD;
Changes in symptoms of anxiety between baseline (T0) and two follow-up points (T1 and T2) will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms of post-traumatic stress disorder</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>The Impact of Events Scale (IES-R; Weiss &amp; Marmar, 1997) is used to measure symptoms of post-traumatic stress disorder (PTSD). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sum of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD using criteria from the Diagnostic Symptom Manual (DSM-IV).&#xD;
Changes in symptoms of post-traumatic stress between the two follow-up points (T1 and T2) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep difficulties</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>The Insomnia Severity Index (ISI; Bastein CH, et al. 2001) is used to assess the nature, severity, and impact of sleep difficulties. The questionnaire consists of 7 items scored on a five-point Likert scale (0=no problem, 4=very severe problem) with scores ranging from 0 to 28.&#xD;
Changes in symptoms sleep difficulties between the two follow-up points (T1 and T2) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hazardous and harmful alcohol drinking</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>Using the three-item Alcohol Use Disorders Identification Test (AUDIT-C). Changes in hazardous and harmful alcohol drinking between baseline (T0) and two follow-up points (T1 and T2) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in loneliness</measure>
    <time_frame>Month 1 (T1) and month 10 (T2)</time_frame>
    <description>Using the three-item Revised UCLA Loneliness Scale. Scores range from 3 to 9 with higher scores indicating higher perceived loneliness.&#xD;
Changes in perceived loneliness between the two follow-up points (T1 and T2) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general physical and mental health</measure>
    <time_frame>Change from last 2 weeks before pandemic to month 1 (T1) and month 10 (T2)</time_frame>
    <description>Change in general physical and mental health, self-rated, on a VAS scale from 0 to 100. Higher scores indicate worse self-reported health.&#xD;
Changes in perceived general physical and mental health between the two follow-up points (T1 and T2) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health symptoms from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.</measure>
    <time_frame>Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).</time_frame>
    <description>Change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms in the last 2 weeks compared to the last 2 weeks of &quot;regular life&quot; before the COVID-19 outbreak.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health well-being from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.</measure>
    <time_frame>Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).</time_frame>
    <description>Change in World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of &quot;regular life&quot; before the COVID-19 outbreak.</description>
  </secondary_outcome>
  <enrollment type="Actual">1092</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Stress, Psychological</condition>
  <condition>Loneliness</condition>
  <condition>Social Isolation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The STRING cohort is comonsed of 1,092 adults residing in private households in the&#xD;
        Metropolitan Region of Santiago, Chile who were born outside of Chile and had lived in the&#xD;
        country for at least 3 months in the first wave.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Country of birth other than Chile&#xD;
&#xD;
          -  Time since arrival to Chile: 3 months (at baseline)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonia Errazuriz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Catolica de Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontificia Universidad Catolica de Chile</name>
      <address>
        <city>Santiago</city>
        <state>RM</state>
        <zip>7550139</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migrants</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Within-group longitudinal design</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT04497636
org study id: 170519004
nct id: NCT04497636
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The mental health of a representative sample of immigrants residing in Santiago, Chile
      (STRING cohort) was assessed nine months prior to the COVID-19 pandemic (T0). Evidence
      suggests that social isolation affects mental health by increasing symptoms of anxiety and
      depression. One of the main components of the current COVID-19 pandemic is the social
      isolation imposed on the population. This study seeks to explore the short (T1) and long-term
      (T2) effects of the pandemic on the psychological wellbeing of the cohort.

      Specific aims are to

        1. Describe the variations in the levels of mental health problems (i.e. symptoms of
           depression, anxiety, post-traumatic stress, sleep difficulties) and wellbeing of
           immigrants during the first (T1) and second follow-up (T2)

        2. Calculate the short (T1) and long-term (T2) effects of social isolation on the levels of
           mental health problems of the immigrant population, and

        3. Identify risk / protective factors associated with a short (T1) and long-term (T2)
           increase in mental health problems
Participants were interviewed at baseline (T0) 8 months before the COVID-19 pandemic. An
      online survey will be applied in two follow-up moments during the pandemic:

        1. At 9 months (also 1 month after lockdown measures imposed) (T1)

        2. At 18 months (also 10 months after lockdown measures imposed) (T2)
observational model: Cohort
time perspective: Prospective
measure: Depressive symptoms
time frame: Month 1 (T1) and month 10 (T2)
description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicate that the patient is within the depressive area. Specific cut-off for primary care samples in Chile have been found yielding a cut-off of 7 and above for high sensitivity and specificity (Saldivia, Aslan, Cova, Vicente, Inostroza & Rincón, 2019).
Changes in depressive symptoms between baseline (T0) and two follow-up points (T1 and T2) will be assessed.
measure: Symptoms of anxiety
time frame: Month 1 (T1) and month 10 (T2)
description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is used to measure symptoms of anxiety and worry. The questionnaire consists of seven items scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for primary care samples in Spain have been found yielding a cut-off of 10 and above for high sensitivity and specificity (García-Campayo et al, 2010).
Changes in symptoms of anxiety between baseline (T0) and two follow-up points (T1 and T2) will be assessed.
measure: Symptoms of post-traumatic stress disorder
time frame: Month 1 (T1) and month 10 (T2)
description: The Impact of Events Scale (IES-R; Weiss & Marmar, 1997) is used to measure symptoms of post-traumatic stress disorder (PTSD). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sum of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD using criteria from the Diagnostic Symptom Manual (DSM-IV).
Changes in symptoms of post-traumatic stress between the two follow-up points (T1 and T2) will be assessed.
measure: Changes in sleep difficulties
time frame: Month 1 (T1) and month 10 (T2)
description: The Insomnia Severity Index (ISI; Bastein CH, et al. 2001) is used to assess the nature, severity, and impact of sleep difficulties. The questionnaire consists of 7 items scored on a five-point Likert scale (0=no problem, 4=very severe problem) with scores ranging from 0 to 28.
Changes in symptoms sleep difficulties between the two follow-up points (T1 and T2) will be assessed.
measure: Changes in hazardous and harmful alcohol drinking
time frame: Month 1 (T1) and month 10 (T2)
description: Using the three-item Alcohol Use Disorders Identification Test (AUDIT-C). Changes in hazardous and harmful alcohol drinking between baseline (T0) and two follow-up points (T1 and T2) will be assessed.
measure: Changes in loneliness
time frame: Month 1 (T1) and month 10 (T2)
description: Using the three-item Revised UCLA Loneliness Scale. Scores range from 3 to 9 with higher scores indicating higher perceived loneliness.
Changes in perceived loneliness between the two follow-up points (T1 and T2) will be assessed.
measure: Change in general physical and mental health
time frame: Change from last 2 weeks before pandemic to month 1 (T1) and month 10 (T2)
description: Change in general physical and mental health, self-rated, on a VAS scale from 0 to 100. Higher scores indicate worse self-reported health.
Changes in perceived general physical and mental health between the two follow-up points (T1 and T2) will be assessed.
measure: Change in mental health symptoms from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.
time frame: Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
description: Change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.
measure: Change in mental health well-being from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.
time frame: Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
description: Change in World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonia Errazuriz, PhD
role: Principal Investigator
affiliation: Universidad Catolica de Chile
facility: 
country: Chile
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Depression
mesh term: Stress, Psychological