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AzTrials

Mental Health Wellness 1NCT04365361

The Psychological Impact of the COVID-19 on Students.

An observational study of Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. The public at large may also experience boredom, disappointment, and irritability under the isolation measures. Depression and anxiety are common mental health problems experienced by university students. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
How many people
300 participants
Where
1 siteHong Kong
Study dates
28 Apr 2020to 31 Dec 2023
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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Part A: An online survey study with non-probabilistic convenience sampling n=384 Part B: Focus group interviews n=32

Who may be able to join

  • Higher education students aged 18 years and above

Who cannot join

  • Subjects refuse to answer this questionnaire

Trial locations and contacts

1 site in 1 country.

LAI YK Agnes, PhD contact

+85239176779238

agneslai@hku.hk

Kelvin MP Wang, PhD contact

+85239176636

mpwang@hku.hk

Hong Kong1 site, 1 recruiting

  • LAI Agnes

    Hong Kong, 852

    LAI Agnes, PhD, 39173628, agneslai@hku.hk

    Kelvin Wang, PhD, 3917, mpwang@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Exploring the Psychological Impact of the COVID-19 on Higher Education Students

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. The public at large may also experience boredom, disappointment, and irritability under the isolation measures. Depression and anxiety are common mental health problems experienced by university students. This survey aims to investigate the psychological impact of COVID 19 on students.

Read the detailed description

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. Infected patients may develop severe and even fatal respiratory diseases (e.g., acute respiratory distress syndrome (ARDS) and acute respiratory failure) ending up in intensive care. Apart from physical suffering, it is not uncommon for confirmed or suspected cases of COVID-19 to suffer from great psychological pressure and other health-related problems. The limited knowledge of the COVID-19 and the overwhelming news may lead to anxiety and fear in the public. The public at large may also experience boredom, disappointment, and irritability under the isolation measures.

Depression and anxiety are common mental health problems experienced by university students. Being in higher education is associated with many stressors and transitional events, and students fall within the age range when common mental health problems are at their developmental peak. Depression and anxiety can impair students' academic performance and social functioning, cause significant burden at university, and potentially affect their future career opportunities. The study includes 2 parts. Part A is an online survey study with non-probabilistic convenience sampling and part B is focus group interviews.

This study aims to explore the psychological impact of COVID-19 and coping methods in higher education students.

Keywords
Stress, Depression, Higher education students, Psychological impact
Medical subject headings
Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress level

    measured by Stress Scale

    Measured: baseline

Secondary outcomes (5)

  1. Anxiety and depressive symptoms

    measured by a 4-item Patient Health Questionnaire

    Measured: baseline

  2. Insomnia symptoms and the associated daytime impairment

    measured by 7-item Insomnia Severity Index

    Measured: baseline

  3. Psychological response to trauma

    measured by a 22-item Impact of Event Scale -Revised

    Measured: baseline

  4. Resilience

    measured by a 2-item Connor-Davidson Resilience Scale

    Measured: baseline

  5. Attitude and practice students regarding preventive measures

    measured by outcome-based questionnaire

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start28 Apr 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04365361
Sponsor's protocol ID
UW20-298
Status last verified
Nov 2021
First submitted
25 Apr 2020
Last updated
10 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It was not included in the participants' consent.

Publications

  • Bao Y, Sun Y, Meng S, Shi J, Lu L. 2019-nCoV epidemic: address mental health care to empower society. Lancet. 2020 Feb 22;395(10224):e37-e38. doi: 10.1016/S0140-6736(20)30309-3. Epub 2020 Feb 7. No abstract available.

    PubMed 32043982

  • Hysenbegasi A, Hass SL, Rowland CR. The impact of depression on the academic productivity of university students. J Ment Health Policy Econ. 2005 Sep;8(3):145-51.

    PubMed 16278502

  • Lai AYK, Cheung GOC, Choi ACM, Wang MP, Chan PSL, Lam AHY, Lo EWS, Lin CC, Lam TH. Mental Health, Support System, and Perceived Usefulness of Support in University Students in Hong Kong Amidst COVID-19 Pandemic: A Mixed-Method Survey. Int J Environ Res Public Health. 2022 Oct 9;19(19):12931. doi: 10.3390/ijerph191912931.

    PubMed 36232227

  • Lai AY, Sit SM, Lam SK, Choi AC, Yiu DY, Lai TT, Ip MS, Lam TH. A Phenomenological Study on the Positive and Negative Experiences of Chinese International University Students From Hong Kong Studying in the U.K. and U.S. in the Early Stage of the COVID-19 Pandemic. Front Psychiatry. 2021 Dec 13;12:738474. doi: 10.3389/fpsyt.2021.738474. eCollection 2021.

    PubMed 34966299

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

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 1 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 10 Dec 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 Hong Kong. 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 LAI YK Agnes, PhD (+85239176779238, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress level (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04365361, which also lists 4 linked publications.

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 10 Dec 2021.

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