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

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

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:

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.

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.

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

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.

Clinical Trials on Mental Health Wellness 1

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