The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families

• Conditions: Mental Health Wellness 1

• Registration Number: NCT04365348
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Study Start: 2020-05-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-27
• Last Update Posted: 2021-11-30
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

• Refusal to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress level	1 month	measured by the 10-item Perceived Stress Scale

Secondary Outcome Measures

Name	Time	Method
Social support	1 month and 3 months	measured by 6-item social support questionnaire
Severity of insomnia symptoms and the associated daytime impairment	1 month and 3 months	measured by the 7-item Insomnia Severity Index
Resilience	1 month and 3 months	measured by the 2-item Connor-Davidson Resilience Scale
Quality of family functioning	1 month and 3 months	measured by 3-item Family Functioning Subscale
Stress level	3 months	measured by the 10-item Perceived Stress Scale
Negative emotion	3 months	measured by the 13-item Hospital Anxiety and Depression Scale
Psychological response to trauma	1 month and 3 months	measured by the 22-item Impact of Event Scale -Revised
Psychological effects	1 month and 3 months	measured by 10-item outcome-based questionnaire

Trial Locations

Locations (1)

Agnes; 🇭🇰 Hong Kong, Hong Kong