Anxiety StateICOSNCT04357418
Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives
An observational study of Anxiety State and COVID-19, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, COVID-19, Isolation, Social
- What is being tested?
- it is a survey
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is about hospital staff and close relatives
Who may be able to join
- For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.
- For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.
- Conditions
- Anxiety State, COVID-19, Isolation, Social, Health Personnel Attitude
- Being tested
- it is a survey
- Keywords
- anxiety, depression, anger, quarantine, health care workers
- Medical subject headings
- Anxiety Disorders, COVID-19, Social Isolation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
it is a surveyOther
this interview can be carried out face to face or remotely.
| Study group | Role | What they receive |
|---|---|---|
| hospital staff | Not described Receives: Other: it is a survey | |
| close relatives. | Not described Receives: Other: it is a survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.
Measured: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.
Measured: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Secondary outcomes (4)
Visual numeric scales assessing anger and stress the ongoing week.
1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".
Measured: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Visual numeric scales assessing anger and stress the ongoing week.
1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".
Measured: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Beck Depression Inventory
The tool provides a quantitative estimate of the intensity of depressive feelings.
Measured: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Beck Depression Inventory
The tool provides a quantitative estimate of the intensity of depressive feelings.
Measured: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clémence ISAAC, Centre hospitalier de Ville-Evrard, France
- Investigators
- Clemence ISAAC, PhD, Principal investigator, CH Ville EvrardDominique JANUEL, Pr, Study director, CH Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357418
- Sponsor's protocol ID
- 10477M-ICOS
- Acronym
- ICOS
- Status last verified
- Jul 2020
- First submitted
- 16 Apr 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
- ClinicalTrials.gov ID
- NCT04357418
- Acronym / sponsor ID
- ICOS / 10477M-ICOS
- Conditions
- Anxiety State, COVID-19, Isolation, Social, Health Personnel Attitude
- Keywords
- anxiety, depression, anger, quarantine, health care workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 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.
The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospital staff | – | Other: it is a survey |
| close relatives. | – | Other: it is a survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is about hospital staff and close relatives
Key inclusion criteria (2 listed)
- For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.
- For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.
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 |
|---|---|---|
| it is a surveythis interview can be carried out face to face or remotely. | Other | close relatives., hospital staff |
Primary outcome
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.
4 secondary outcomes
Visual numeric scales assessing anger and stress the ongoing week.
Time frame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Visual numeric scales assessing anger and stress the ongoing week.
Time frame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Beck Depression Inventory
Time frame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Beck Depression Inventory
Time frame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
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 3 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Clemence ISAAC, PhD principal investigator
CH Ville Evrard
Dominique JANUEL, Pr study director
CH Ville Evrard
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 Anxiety State and COVID-19, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
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 2 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 3 Aug 2020. 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 France. 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?
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI) (time frame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)). The study lists 2 primary outcomes in all. 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 3 Aug 2020.