Clinical trial NCT04365348: The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families
Official title: Exploring the Psychological Impact of the COVID-19 Outbreak on COVID-19 Survivors and Their Families
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Wellness 1
Keywords: Stress
Anxiety
Depression
Families
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2020-04-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 Survivors: 300; Family members of COVID-19 Survivors:300

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress level
timeFrame: 1 month
Secondary outcomes:
measure: Stress level
timeFrame: 3 months
measure: Negative emotion
timeFrame: 3 months
measure: Psychological response to trauma
timeFrame: 1 month and 3 months
measure: Severity of insomnia symptoms and the associated daytime impairment
timeFrame: 1 month and 3 months
measure: Resilience
timeFrame: 1 month and 3 months
measure: Quality of family functioning
timeFrame: 1 month and 3 months
measure: Social support
timeFrame: 1 month and 3 months
measure: Psychological effects
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Agnes
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.