- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04365348
The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families
November 27, 2021 updated by: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
Exploring the Psychological Impact of the COVID-19 Outbreak on COVID-19 Survivors and Their Families
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level.
Currently, there is little information on the mental health implications of exposure amongst COVID-19 survivors and their family members.
Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19.
This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Since the 2019 coronavirus disease (COVID-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention.
Infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ARDS) and acute respiratory failure, ending up in intensive care.
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level.
The stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood.
The psychological impact of COVID-19 may also evolve and last for a prolonged period after discharge from the hospital.
However, there is currently little information on the mental health implications of exposure amongst COVID-19 survivors and their family members.
Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19.
This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Agnes YK Lai, PhD
- Phone Number: 39176328
- Email: agneslai@hku.hk
Study Contact Backup
- Name: Mary SM Ip, MD
- Phone Number: 22554455
- Email: msmip@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong, 852
- Recruiting
- Agnes
-
Principal Investigator:
- Agnes YK Lai, PhD
-
Contact:
- Agnes YK Lai
- Email: agneslai@hku.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COVID-19 Survivors: 300; Family members of COVID-19 Survivors:300
Description
Inclusion Criteria:
- COVID-19 survivors (i.e., diagnosed with COVID-19 and discharged from the hospital) and/or a family member of a COVID-19 survivor;
- Aged 18 years or above;
- No medical diagnosis of psychiatric illness
Exclusion Criteria:
• Refusal to give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress level
Time Frame: 1 month
|
measured by the 10-item Perceived Stress Scale
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress level
Time Frame: 3 months
|
measured by the 10-item Perceived Stress Scale
|
3 months
|
|
Negative emotion
Time Frame: 3 months
|
measured by the 13-item Hospital Anxiety and Depression Scale
|
3 months
|
|
Psychological response to trauma
Time Frame: 1 month and 3 months
|
measured by the 22-item Impact of Event Scale -Revised
|
1 month and 3 months
|
|
Severity of insomnia symptoms and the associated daytime impairment
Time Frame: 1 month and 3 months
|
measured by the 7-item Insomnia Severity Index
|
1 month and 3 months
|
|
Resilience
Time Frame: 1 month and 3 months
|
measured by the 2-item Connor-Davidson Resilience Scale
|
1 month and 3 months
|
|
Quality of family functioning
Time Frame: 1 month and 3 months
|
measured by 3-item Family Functioning Subscale
|
1 month and 3 months
|
|
Social support
Time Frame: 1 month and 3 months
|
measured by 6-item social support questionnaire
|
1 month and 3 months
|
|
Psychological effects
Time Frame: 1 month and 3 months
|
measured by 10-item outcome-based questionnaire
|
1 month and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, Chan MT, Wong TK, Choy KM, Chu CM, Lee PW, Tsang KW. Stress and psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004 Jun;49(6):385-90. doi: 10.1177/070674370404900607.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2020
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
April 25, 2020
First Submitted That Met QC Criteria
April 25, 2020
First Posted (Actual)
April 28, 2020
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 27, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW20-300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It has not been mentioned in the participants' consent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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