<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/NCT04420416</url>
  </required_header>
  <id_info>
    <org_study_id>Mental01</org_study_id>
    <nct_id>NCT04420416</nct_id>
  </id_info>
  <brief_title>Mental Health and Academic Performance in COVID-19</brief_title>
  <acronym>PANDEMIC</acronym>
  <official_title>dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Mexicano del Seguro Social</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 aims to identify the preference of the class modalities (classroom or online) in&#xD;
      undergraduate and graduate students. Additionally, to explore if the presence of any mental&#xD;
      state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their&#xD;
      perception of academic performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 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>Academic Self-Concept Scale Score</measure>
    <time_frame>up to 3 months</time_frame>
    <description>This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PHQ-9 Score</measure>
    <time_frame>up to 3 months</time_frame>
    <description>This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GAD-7 Score</measure>
    <time_frame>up to 3 months</time_frame>
    <description>This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference of teaching method</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Students' preference of classroom or online classes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self perceived academic performance</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Students' perception of changes in their academic performance: got better, worse, or stayed the same.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Academic grades changes</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Students' perception of changes in their grades: got better, worse, or stayed the same.</description>
  </primary_outcome>
  <enrollment type="Anticipated">720</enrollment>
  <condition>Depression, Anxiety</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>The investigators will use the Spanish language validated version of the Academic Self-Concept Scale (ASCS), the Patient Health Questionnaire-9 (PHQ-9) depression screening scale, and the General Anxiety Disorder-7 (GAD-7) screening scale. Additionally, the sample will be asked about their gender, age, preference of teaching modality, and finally, if the participants have perceived a change in their performance or any change in their grades.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Undergraduate and graduate students who attend an online university course.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  Students of any undergraduate or graduate course who are attending their semester&#xD;
             online&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who are not attending an online course&#xD;
&#xD;
          -  Students who are not registered in a university undergraduate or graduate course.&#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>
  <location>
    <facility>
      <name>Instituto Mexicano del Seguro Social</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44329</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alejandro Gonzalez Ojeda, PhD</last_name>
      <phone>+52333170060</phone>
      <phone_ext>31309</phone_ext>
      <email>avygail5@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Mexicano del Seguro Social</investigator_affiliation>
    <investigator_full_name>GONZALEZ-OJEDA ALEJANDRO</investigator_full_name>
    <investigator_title>Investigador Titular D</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Public health</keyword>
  <keyword>Academic performance</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>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan of making individual participant data available.</ipd_description>
  </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/NCT04420416
org study id: Mental01
nct id: NCT04420416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to identify the preference of the class modalities (classroom or online) in
      undergraduate and graduate students. Additionally, to explore if the presence of any mental
      state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their
      perception of academic performance.
observational model: Cohort
time perspective: Cross-Sectional
measure: Academic Self-Concept Scale Score
time frame: up to 3 months
description: This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70.
measure: PHQ-9 Score
time frame: up to 3 months
description: This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.
measure: GAD-7 Score
time frame: up to 3 months
description: This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.
measure: Preference of teaching method
time frame: up to 3 months
description: Students' preference of classroom or online classes.
measure: Self perceived academic performance
time frame: up to 3 months
description: Students' perception of changes in their academic performance: got better, worse, or stayed the same.
measure: Academic grades changes
time frame: up to 3 months
description: Students' perception of changes in their grades: got better, worse, or stayed the same.
intervention type: Other
intervention name: Survey
description: The investigators will use the Spanish language validated version of the Academic Self-Concept Scale (ASCS), the Patient Health Questionnaire-9 (PHQ-9) depression screening scale, and the General Anxiety Disorder-7 (GAD-7) screening scale. Additionally, the sample will be asked about their gender, age, preference of teaching modality, and finally, if the participants have perceived a change in their performance or any change in their grades.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Mexicano del Seguro Social
investigator full name: GONZALEZ-OJEDA ALEJANDRO
investigator title: Investigador Titular D
mesh term: COVID-19
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: There is no plan of making individual participant data available.