Stress DisorderSCEINCT04491071
Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
An observational study of Stress Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in 2 countries.
Trial summary
The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorder
- What is being tested?
- Generalized Anxiety Disorder-7 (GAD 7), Background questionnaire and Impact of COVID-19 questionnaire
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Oct 2020to 29 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health Volunteers
Who may be able to join
- Adult volunteer who agreed to answer the questionnaires
- Age ≥ 18 years old
- Adult affiliated or having a duty to a social security scheme
Who cannot join
- Children under 18 years old
- Inability to understand information letter, consent, or to use online questionnaire
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42270
United Kingdom1 site
Centre de Recherche et d'Innovation Clinique
Glasgow
About this study
The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).
Read the detailed description
The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. There are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The COVID-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life.
There are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. The stress will first be measured on standardized anxiety GAD-7scale but also on more parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will be recorded.
Level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. Risk factors will be looked for, by multi parametric data analysis.
The survey has been built in a user-friendly, accessible way so the investigators can expect a high number of participants (at least 400), especially as people are highly concerned by the situation and will be motivated to take part.
- Conditions
- Stress Disorder
- Being tested
- Generalized Anxiety Disorder-7 (GAD 7), Background questionnaire, Impact of COVID-19 questionnaire, Confinement and Communication During the COVID-19 Pandemic, Mental Health questionnaire
- Keywords
- COVID-19, Stress, Effects on Immunity, Anxiety
- Medical subject headings
- Stress Disorders, Traumatic, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generalized Anxiety Disorder-7 (GAD 7)Diagnostic test
test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.
Background questionnaireDiagnostic test
questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
Impact of COVID-19 questionnaireDiagnostic test
status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)
Confinement and Communication During the COVID-19 PandemicDiagnostic test
know the experience of containment and isolation during the pandemic
Mental Health questionnaireDiagnostic test
welfare effect
Patient Health Questionnaire (PHQ-9)Diagnostic test
assess depression during the pandemic
Post Traumatic Stress Disorder questionnaire (PTSD-8)Diagnostic test
Assessing the trauma of subjects during the pandemic
Experiences in Close Relationship Scale questionnaire (ECR-S)Diagnostic test
Measuring social ties and attachment of subjects
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | volunteers over 18 years of age Receives: Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7); Diagnostic Test: Background questionnaire; Diagnostic Test: Impact of COVID-19 questionnaire; Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic; Diagnostic Test: Mental Health questionnaire; Diagnostic Test: Patient Health Questionnaire (PHQ-9); Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8); Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the Generalized Anxiety Disorder (GAD-7)
test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.
Scored between 0-21:
Cut offs:
- 0-4 = None
- 5-9 = Mild anxiety
- 10-14 = Moderate anxiety
- 15-21 = Severe anxiety
Measured: 5 Minutes
Secondary outcomes (4)
Results of the Mental Health questionnaire
Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.
Measured: 5 minutes
Results of the Patient Health Questionnaire (PHQ-9)
assess depression during the pandemic
Scored between 0-27:
Cut offs:
- 0-4 = None
- 5-9 = Mild depression
- 10-14 = Moderate depression
- 15-19 = Moderately severe depression
- 20-27 = Severe depression
Measured: 5 minutes
Results of the Post Traumatic Stress Disorder (PTSD-8)
Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.
Measured: 5 minutes
Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)
Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start22 Oct 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Why it stopped: The study was stopped due to lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude LAMBERT, MD PhD HDR, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491071
- Sponsor's protocol ID
- 20CH129
- Other IDs
- IRBN972020/CHUSTE
- Acronym
- SCEI
- Status last verified
- Apr 2023
- First submitted
- 27 Jul 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
- ClinicalTrials.gov ID
- NCT04491071
- Acronym / sponsor ID
- SCEI / 20CH129
- Conditions
- Stress Disorder
- Keywords
- COVID-19, Stress, Effects on Immunity, Anxiety
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of inclusions
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 29 Jul 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 aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).
Detailed description
The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. There are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The COVID-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life.
There are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. The stress will first be measured on standardized anxiety GAD-7scale but also on more parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will be recorded.
Level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. Risk factors will be looked for, by multi parametric data analysis.
The survey has been built in a user-friendly, accessible way so the investigators can expect a high number of participants (at least 400), especially as people are highly concerned by the situation and will be motivated to take part.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7), Diagnostic Test: Background questionnaire, Diagnostic Test: Impact of COVID-19 questionnaire, Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic, Diagnostic Test: Mental Health questionnaire, Diagnostic Test: Patient Health Questionnaire (PHQ-9), Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8), Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S)volunteers over 18 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health Volunteers
Key inclusion criteria (3 listed)
- Adult volunteer who agreed to answer the questionnaires
- Age ≥ 18 years old
- Adult affiliated or having a duty to a social security scheme
Key exclusion criteria (2 listed)
- Children under 18 years old
- Inability to understand information letter, consent, or to use online questionnaire
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 |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD 7)test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. | Diagnostic test | Volunteers |
| Background questionnairequestionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants | Diagnostic test | Volunteers |
| Impact of COVID-19 questionnairestatus of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) | Diagnostic test | Volunteers |
| Confinement and Communication During the COVID-19 Pandemicknow the experience of containment and isolation during the pandemic | Diagnostic test | Volunteers |
| Mental Health questionnairewelfare effect | Diagnostic test | Volunteers |
| Patient Health Questionnaire (PHQ-9)assess depression during the pandemic | Diagnostic test | Volunteers |
| Post Traumatic Stress Disorder questionnaire (PTSD-8)Assessing the trauma of subjects during the pandemic | Diagnostic test | Volunteers |
| Experiences in Close Relationship Scale questionnaire (ECR-S)Measuring social ties and attachment of subjects | Diagnostic test | Volunteers |
Primary outcome
Results of the Generalized Anxiety Disorder (GAD-7)
Time frame: 5 Minutes
test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: * 0-4 = None * 5-9 = Mild anxiety * 10-14 = Moderate anxiety * 15-21 = Severe anxiety
4 secondary outcomes
Results of the Mental Health questionnaire
Time frame: 5 minutes
Results of the Patient Health Questionnaire (PHQ-9)
Time frame: 5 minutes
Results of the Post Traumatic Stress Disorder (PTSD-8)
Time frame: 5 minutes
Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- 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.
Claude LAMBERT, MD PhD HDR principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in 2 countries.
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 2 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: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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 was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
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?
Results of the Generalized Anxiety Disorder (GAD-7) (time frame: 5 Minutes). 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 Apr 2023.