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

Mental Health Wellness 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365348
• Other study ID #: UW20-300
• Status: Recruiting
• Start date: May 27, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2021
• Source: The University of Hong Kong
• Contact: Agnes YK Lai, PhD
• Phone: 39176328
• Email: agneslai[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mental Health Wellness 1

Locations

Country	Name	City	State
Hong Kong	Agnes	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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