Depression, AnxietyPANDEMICNCT04420416
Mental Health and Academic Performance in COVID-19
An observational study of Depression, Anxiety, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Survey
- How many people
- 720 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2020to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Undergraduate and graduate students who attend an online university course.
Who may be able to join
- > 18 years
- Students of any undergraduate or graduate course who are attending their semester online
Who cannot join
- Students who are not attending an online course
- Students who are not registered in a university undergraduate or graduate course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.
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.
- Conditions
- Depression, Anxiety
- Being tested
- Survey
- Keywords
- COVID-19, Depression, Anxiety, Public health, Academic performance
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic Self-Concept Scale Score
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.
Measured: up to 3 months
PHQ-9 Score
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.
Measured: up to 3 months
GAD-7 Score
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.
Measured: up to 3 months
Preference of teaching method
Students' preference of classroom or online classes.
Measured: up to 3 months
Self perceived academic performance
Students' perception of changes in their academic performance: got better, worse, or stayed the same.
Measured: up to 3 months
Academic grades changes
Students' perception of changes in their grades: got better, worse, or stayed the same.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420416
- Sponsor's protocol ID
- Mental01
- Acronym
- PANDEMIC
- Status last verified
- Sep 2023
- First submitted
- 4 Jun 2020
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan of making individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.
- ClinicalTrials.gov ID
- NCT04420416
- Acronym / sponsor ID
- PANDEMIC / Mental01
- Conditions
- Depression, Anxiety
- Keywords
- COVID-19, Depression, Anxiety, Public health, Academic performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Undergraduate and graduate students who attend an online university course.
Key inclusion criteria (2 listed)
- > 18 years
- Students of any undergraduate or graduate course who are attending their semester online
Key exclusion criteria (2 listed)
- Students who are not attending an online course
- Students who are not registered in a university undergraduate or graduate course.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyThe 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No. There is no plan of making individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic Self-Concept Scale Score (time frame: up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.