Psychological DistressNCT04368312
Psychological Impairment Due to Covid-19
An observational study of Psychological Distress and Quality of Life, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Quality of Life
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 6 May 2020to 30 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inclusion of all persons which can be attributed to hospital stuff, those include doctors and nurses (male/female)
Who may be able to join
- Hospital staff (doctors and nurses)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Impairment Due to Covid-19 in Hospital Staff
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.
Read the detailed description
Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.
- Conditions
- Psychological Distress, Quality of Life
- Being tested
- No intervention
- Keywords
- quality of life, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, just of questionnaire including validated tests
| Study group | Role | What they receive |
|---|---|---|
| Health care providers/hospital staff | The targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL5 Questionnaire
Validated 20-items questionnaire for PTSD
Measured: 14 days
BSI - Brief symptom inventory
The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.
Measured: 14 days
PHQD
Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment
Measured: 14 days
WHO - QoL BREF
Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems.
Measured: 14 days
STAXI
The State-Trait Anger Expression Inventory is used to measure the expressions \& control of anger
Measured: 14 days
AUDIT questionnaire
The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start6 May 2020
- Primary completion30 Sep 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368312
- Sponsor's protocol ID
- TEMP553914-BO
- Status last verified
- May 2021
- First submitted
- 9 Apr 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wesemann U, Hadjamu N, Wakili R, Willmund G, Vogel J, Rassaf T, Siebermair J. Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19. Health Equity. 2021 Apr 19;5(1):181-184. doi: 10.1089/heq.2020.0119. eCollection 2021.
PubMed 33937603
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impairment Due to Covid-19 in Hospital Staff
- ClinicalTrials.gov ID
- NCT04368312
- Acronym / sponsor ID
- TEMP553914-BO
- Conditions
- Psychological Distress, Quality of Life
- Keywords
- quality of life, psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Apr 2020 (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.
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.
Detailed description
Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care providers/hospital staff | – | Other: No interventionThe targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion of all persons which can be attributed to hospital stuff, those include doctors and nurses (male/female)
Key inclusion criteria (1 listed)
- Hospital staff (doctors and nurses)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention, just of questionnaire including validated tests | Other | Health care providers/hospital staff |
Primary outcome
PCL5 Questionnaire
Time frame: 14 days
Validated 20-items questionnaire for PTSD
BSI - Brief symptom inventory
Time frame: 14 days
The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.
PHQD
Time frame: 14 days
Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment
WHO - QoL BREF
Time frame: 14 days
Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems.
STAXI
Time frame: 14 days
The State-Trait Anger Expression Inventory is used to measure the expressions \& control of anger
AUDIT questionnaire
Time frame: 14 days
The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption
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 6 May 2021.
- Derived from this study: PubMed 33937603Wesemann U, Hadjamu N, Wakili R, Willmund G, Vogel J, Rassaf T, Siebermair J. Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19. Health Equity. 2021 Apr 19;5(1):181-184. doi: 10.1089/heq.2020.0119. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psychological Distress and Quality of Life, run by University Hospital, Essen at 1 site in Germany.
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 6 May 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 Germany. 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?
PCL5 Questionnaire (time frame: 14 days). The study lists 6 primary outcomes in all. 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 NCT04368312, which also lists 1 linked publication.
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 6 May 2021.