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Status unknownNCT04365348Updated Nov 30, 2021

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

An observational study in Mental Health Wellness 1, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-30.

Sponsored by The University of Hong Kong · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mental Health Wellness 1

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Keywords

  • Stress
  • Anxiety
  • Depression
  • Families
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 300 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID-19 Survivors: 300; Family members of COVID-19 Survivors: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

Exclusion criteria

Exclusion Criteria:

  • Refusal to give consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Stress level

    measured by the 10-item Perceived Stress Scale

    Time frame: 1 month

Secondary outcomes

  1. Stress level

    measured by the 10-item Perceived Stress Scale

    Time frame: 3 months

  2. Negative emotion

    measured by the 13-item Hospital Anxiety and Depression Scale

    Time frame: 3 months

  3. Psychological response to trauma

    measured by the 22-item Impact of Event Scale -Revised

    Time frame: 1 month and 3 months

  4. Severity of insomnia symptoms and the associated daytime impairment

    measured by the 7-item Insomnia Severity Index

    Time frame: 1 month and 3 months

  5. Resilience

    measured by the 2-item Connor-Davidson Resilience Scale

    Time frame: 1 month and 3 months

  6. Quality of family functioning

    measured by 3-item Family Functioning Subscale

    Time frame: 1 month and 3 months

  7. Social support

    measured by 6-item social support questionnaire

    Time frame: 1 month and 3 months

  8. Psychological effects

    measured by 10-item outcome-based questionnaire

    Time frame: 1 month and 3 months

07

Study locations

1 of 1 sites recruiting
  • Agnes
    Hong Kong, 852, Hong Kong
    • Agnes YK Lai · Contact · agneslai@hku.hk
    • Agnes YK Lai, PhD · Principal investigator
    Recruiting
08

References and documents

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. doi: 10.1001/jama.2021.2336. PubMed 32031570 ↗
  • 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. PubMed 15283533 ↗

Individual participant data

Plan to share: No — It has not been mentioned in the participants' consent

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04365348
Lead sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
Responsible party
Dr. Agnes Yuen-Kwan Lai (Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Apr 28, 2020
Start date
May 27, 2020
Primary completion
May 31, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Nov 30, 2021

Study contacts

Agnes YK Lai, PhD
Contact
agneslai@hku.hk
39176328
Mary SM Ip, MD
Contact
msmip@hku.hk
22554455
Agnes YK Lai, PhD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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