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Mental Health Wellness 1NCT04365348

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

An observational study of Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Mental Health Wellness 1
How many people
300 participants
Where
1 siteHong Kong
Study dates
27 May 2020to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Refusal to give consent

Trial locations and contacts

1 site in 1 country.

Agnes YK Lai, PhD contact

39176328

agneslai@hku.hk

Mary SM Ip, MD contact

22554455

msmip@hku.hk

Hong Kong1 site, 1 recruiting

  • Agnes

    Hong Kong, 852

    Agnes YK Lai, agneslai@hku.hk

    Agnes YK Lai, PhD

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

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.

Keywords
Stress, Anxiety, Depression, Families
Medical subject headings
Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress level

    measured by the 10-item Perceived Stress Scale

    Measured: 1 month

Secondary outcomes (8)

  1. Stress level

    measured by the 10-item Perceived Stress Scale

    Measured: 3 months

  2. Negative emotion

    measured by the 13-item Hospital Anxiety and Depression Scale

    Measured: 3 months

  3. Psychological response to trauma

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

    Measured: 1 month and 3 months

  4. Severity of insomnia symptoms and the associated daytime impairment

    measured by the 7-item Insomnia Severity Index

    Measured: 1 month and 3 months

  5. Resilience

    measured by the 2-item Connor-Davidson Resilience Scale

    Measured: 1 month and 3 months

  6. Quality of family functioning

    measured by 3-item Family Functioning Subscale

    Measured: 1 month and 3 months

  7. Social support

    measured by 6-item social support questionnaire

    Measured: 1 month and 3 months

  8. Psychological effects

    measured by 10-item outcome-based questionnaire

    Measured: 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start27 May 2020
  3. Primary completion31 May 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04365348
Sponsor's protocol ID
UW20-300
Status last verified
Nov 2021
First submitted
25 Apr 2020
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It has not been mentioned in the participants' consent

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Agnes YK Lai, PhD (39176328, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress level (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04365348, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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