Depression UnipolarNCT04978220
Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients
An observational study of Depression Unipolar and Insomnia, run by Peking University Sixth Hospital at 1 site in China.
Trial summary
The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Depression Unipolar, Insomnia
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2020to 31 May 2021
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There were 644 medical staff on duty in the hospital, of which 360 people participated in the baseline survey, accounting for 55.90%. In the follow-up survey after one year, 199 out of 360 people in the baseline participated, accounting for 55.28% of the baseline.
Who may be able to join
- all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups
Who cannot join
- Incomplete information fills in, which affects the result analysis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Follow-up Study on Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital Where Staff Are Infected With COVID-19
The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.
Read the detailed description
A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.
- Conditions
- Depression Unipolar, Insomnia
- Medical subject headings
- Depressive Disorder, Major, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
HADS is used to assess the anxiety and depression symptoms of medical staff in general hospitals. There are 14 items in total, divided into two parts-the anxiety subscale (HADS-A) and the depression subscale (HADS-D). A total score of 0-7 is classified as asymptomatic, 8-10 is classified as marginal/suspicious, and 11-21 is classified as abnormal.
Measured: 1 year
Secondary outcomes (1)
Acute Stress Disorder Scale (ASDS)
ASDS is a self-rating scale, compiled according to the diagnostic criteria of the fourth edition of the "Manual of Diagnosis and Statistics of Mental Disorders", used to assess acute stress disorder (ASD) symptoms and predict post-traumatic stress disorder (PTSD).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start27 Jun 2020
- Primary completion27 Jun 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression UnipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueqin Wang, Peking University Sixth Hospital
- Investigators
- Xueqin Wang, MD, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978220
- Sponsor's protocol ID
- 2020-021(BMR)
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study on Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital Where Staff Are Infected With COVID-19
- ClinicalTrials.gov ID
- NCT04978220
- Acronym / sponsor ID
- 2020-021(BMR)
- Conditions
- Depression Unipolar, Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.
Detailed description
A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There were 644 medical staff on duty in the hospital, of which 360 people participated in the baseline survey, accounting for 55.90%. In the follow-up survey after one year, 199 out of 360 people in the baseline participated, accounting for 55.28% of the baseline.
Key inclusion criteria (1 listed)
- all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups
Key exclusion criteria (1 listed)
- Incomplete information fills in, which affects the result analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 year
HADS is used to assess the anxiety and depression symptoms of medical staff in general hospitals. There are 14 items in total, divided into two parts-the anxiety subscale (HADS-A) and the depression subscale (HADS-D). A total score of 0-7 is classified as asymptomatic, 8-10 is classified as marginal/suspicious, and 11-21 is classified as abnormal.
1 secondary outcome
Acute Stress Disorder Scale (ASDS)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueqin Wang, MD principal investigator
Peking University Sixth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Unipolar and Insomnia, run by Peking University Sixth Hospital at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 27 Jul 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.