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Mental Health and Academic Performance in COVID-19 (PANDEMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420416
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Tracking Information
First Submitted Date June 4, 2020
First Posted Date June 9, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date April 1, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2020)
  • Academic Self-Concept Scale Score [ Time Frame: up to 3 months ]
    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.
  • PHQ-9 Score [ Time Frame: up to 3 months ]
    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.
  • GAD-7 Score [ Time Frame: up to 3 months ]
    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.
  • Preference of teaching method [ Time Frame: up to 3 months ]
    Students' preference of classroom or online classes.
  • Self perceived academic performance [ Time Frame: up to 3 months ]
    Students' perception of changes in their academic performance: got better, worse, or stayed the same.
  • Academic grades changes [ Time Frame: up to 3 months ]
    Students' perception of changes in their grades: got better, worse, or stayed the same.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mental Health and Academic Performance in COVID-19
Official Title dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Undergraduate and graduate students who attend an online university course.
Condition Depression, Anxiety
Intervention Other: Survey
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 Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2020)
720
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • > 18 years
  • Students of any undergraduate or graduate course who are attending their semester online

Exclusion Criteria:

  • Students who are not attending an online course
  • Students who are not registered in a university undergraduate or graduate course.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04420416
Other Study ID Numbers Mental01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan of making individual participant data available.
Responsible Party GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
Study Sponsor Instituto Mexicano del Seguro Social
Collaborators Not Provided
Investigators Not Provided
PRS Account Instituto Mexicano del Seguro Social
Verification Date July 2020