Covid19NCT04746443
Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey
An observational study of Covid19, run by King Khalid University at 1 site in Saudi Arabia.
Trial summary
The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Covid19
- What is being tested?
- NOT APPLICABLE (NA)
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Dec 2020to 8 Mar 2021
- 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: College going students
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khalid University
Abhā, 'Asir Region
SNEHIL DIXIT, PhD
About this study
Official title: Impact of Covid-19 Affliction on Psychological and Mental Health of the College Students: Cross-Sectional Survey
The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).
Read the detailed description
Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students
Methodology:
Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests
- Conditions
- Covid19
- Being tested
- NOT APPLICABLE (NA)
- Keywords
- college students, CORONA, COVID-19, Graduates
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOT APPLICABLE (NA)Other
THE INTERVENTION GROUP IS NOT APPLICABLE TO THE CURRENT STUDY DESIGN
| Study group | Role | What they receive |
|---|---|---|
| STUDENTS | COLLEGE STUDENTS WITH POSITIVE COVID-19 TEST Receives: Other: NOT APPLICABLE (NA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVENT IMPACT SCALE - REVISED
The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. It is a revised version of the older version, the 15-item IES (Horowitz, Wilner, \& Alvarez, 1979). The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD
Measured: Within 1 month of the impact of COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start8 Dec 2020
- Primary completion8 Mar 2021 (estimated)
- Study completion8 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Snehil Dixit, King Khalid University
- Investigators
- SNEHIL DIXIT, PhD, Principal investigator, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746443
- Sponsor's protocol ID
- ECM#2020-2501
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Data cannot be shared without the prior approval of the University
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 Affliction on Psychological and Mental Health of the College Students: Cross-Sectional Survey
- ClinicalTrials.gov ID
- NCT04746443
- Acronym / sponsor ID
- ECM#2020-2501
- Conditions
- Covid19
- Keywords
- college students, CORONA, COVID-19, Graduates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 8 Mar 2021 (estimated)
- Study completion
- 8 Mar 2021 (estimated)
- First posted
- 9 Feb 2021 (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.
The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).
Detailed description
Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students
Methodology:
Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STUDENTS | – | Other: NOT APPLICABLE (NA)COLLEGE STUDENTS WITH POSITIVE COVID-19 TEST |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- College going students
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NOT APPLICABLE (NA)THE INTERVENTION GROUP IS NOT APPLICABLE TO THE CURRENT STUDY DESIGN | Other | STUDENTS |
Primary outcome
EVENT IMPACT SCALE - REVISED
Time frame: Within 1 month of the impact of COVID-19
The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. It is a revised version of the older version, the 15-item IES (Horowitz, Wilner, \& Alvarez, 1979). The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No. The Data cannot be shared without the prior approval of the University
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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.
SNEHIL DIXIT, PhD principal investigator
King Khalid University
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 Covid19, run by King Khalid University at 1 site in Saudi Arabia.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SNEHIL DIXIT, PHD (+966559105324, snehil@kku.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVENT IMPACT SCALE - REVISED (time frame: Within 1 month of the impact of COVID-19). 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 9 Feb 2021.