The Psychological Impact of the COVID-19 on Students. | NCT04365361

Studies
The Psychological Impact of the COVID-19 on Students.

NCT04365361

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Dec 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Mental Health Wellness 1

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Apr 25, 2020

First Submission Date that Met QC Criteria

Apr 25, 2020

First Posted Date

Apr 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2021

Last Update Posted Date

Dec 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Agnes Yuen-Kwan Lai, Assistant Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. This survey aims to investigate the psychological impact of COVID 19 on students.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress level	measured by Stress Scale	baseline

Secondary Outcomes

Measure	Description	Time Frame
Anxiety and depressive symptoms	measured by a 4-item Patient Health Questionnaire	baseline
Insomnia symptoms and the associated daytime impairment	measured by 7-item Insomnia Severity Index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Higher education students aged 18 years and above

Exclusion Criteria:

• Subjects refuse to answer this questionnaire

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Part A: An online survey study with non-probabilistic convenience sampling n=384

Part B: Focus group interviews n=32

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LAI YK Agnes, PhD	Contact	+85239176779238		agneslai@hku.hk
Kelvin MP Wang, PhD	Contact	+85239176636		mpwang@hku.hk

Overall Officials

Name	Affiliation	Role
Agnes YK Lai, PhD	School of Nursing, The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LAI Agnes	Recruiting	Hong Kong		852	Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32043982	Background	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.
16278502	Background	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior