<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/NCT04440098</url>
  </required_header>
  <id_info>
    <org_study_id>20200446</org_study_id>
    <nct_id>NCT04440098</nct_id>
  </id_info>
  <brief_title>Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology</brief_title>
  <official_title>Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
      This study seeks to gather data and insight on epidemiologic trends of loneliness and other&#xD;
      behaviors in the wake of the CDC recommended &quot;social distancing&quot; during the COVID-19&#xD;
      pandemic. The objective of this study is to use a cross-sectional survey to assess the impact&#xD;
      of COVID-19's associated recommendations (social distancing, self-isolation, and&#xD;
      self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety,&#xD;
      substance abuse) on young adults (18-35 years old).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 22, 2020</start_date>
  <completion_date type="Actual">May 11, 2020</completion_date>
  <primary_completion_date type="Actual">May 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Loneliness as evaluated by the UCLA loneliness scale</measure>
    <time_frame>Day 1</time_frame>
    <description>University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol Use as evaluated by the AUDIT</measure>
    <time_frame>Day 1</time_frame>
    <description>Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug Use as evaluated by the DAST-10</measure>
    <time_frame>Day 1</time_frame>
    <description>The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety as evaluated by GAD-7</measure>
    <time_frame>Day 1</time_frame>
    <description>The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression as assessed by CES-D-10</measure>
    <time_frame>Day 1</time_frame>
    <description>The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1008</enrollment>
  <condition>Loneliness</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Alcohol Abuse</condition>
  <condition>Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Isolated Observational group</arm_group_label>
    <description>All participants socially restricted as a result of COVID-19</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  18-35 years old&#xD;
&#xD;
          -  Currently living in the United States&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Those under 18 years, or older than 35 years&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Non-English-speaking adults&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viviana E Horigian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Viviana Horigian</investigator_full_name>
    <investigator_title>Professor, Educator Track</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Substance-Related 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/NCT04440098
org study id: 20200446
nct id: NCT04440098
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to gather data and insight on epidemiologic trends of loneliness and other
      behaviors in the wake of the CDC recommended "social distancing" during the COVID-19
      pandemic. The objective of this study is to use a cross-sectional survey to assess the impact
      of COVID-19's associated recommendations (social distancing, self-isolation, and
      self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety,
      substance abuse) on young adults (18-35 years old).
observational model: Case-Only
time perspective: Cross-Sectional
measure: Loneliness as evaluated by the UCLA loneliness scale
time frame: Day 1
description: University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
measure: Alcohol Use as evaluated by the AUDIT
time frame: Day 1
description: Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.
measure: Drug Use as evaluated by the DAST-10
time frame: Day 1
description: The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.
measure: Anxiety as evaluated by GAD-7
time frame: Day 1
description: The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.
measure: Depression as assessed by CES-D-10
time frame: Day 1
description: The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.
arm group label: Isolated Observational group
description: All participants socially restricted as a result of COVID-19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Viviana E Horigian, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Viviana Horigian
investigator title: Professor, Educator Track
mesh term: Alcoholism
mesh term: Substance-Related Disorders
sharing ipd: No