Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
NCT ID: NCT04491071
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
150 participants
OBSERVATIONAL
2020-10-22
2021-09-29
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Volunteers
volunteers over 18 years of age
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.
Background questionnaire
questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
Impact of COVID-19 questionnaire
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 Pandemic
know the experience of containment and isolation during the pandemic
Mental Health questionnaire
welfare effect
Patient Health Questionnaire (PHQ-9)
assess depression during the pandemic
Post Traumatic Stress Disorder questionnaire (PTSD-8)
Assessing the trauma of subjects during the pandemic
Experiences in Close Relationship Scale questionnaire (ECR-S)
Measuring social ties and attachment of subjects
Interventions
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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.
Background questionnaire
questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
Impact of COVID-19 questionnaire
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 Pandemic
know the experience of containment and isolation during the pandemic
Mental Health questionnaire
welfare effect
Patient Health Questionnaire (PHQ-9)
assess depression during the pandemic
Post Traumatic Stress Disorder questionnaire (PTSD-8)
Assessing the trauma of subjects during the pandemic
Experiences in Close Relationship Scale questionnaire (ECR-S)
Measuring social ties and attachment of subjects
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Adult affiliated or having a duty to a social security scheme
Exclusion Criteria
* Inability to understand information letter, consent, or to use online questionnaire
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Claude LAMBERT, MD PhD HDR
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, , France
Centre de Recherche et d'Innovation Clinique
Glasgow, , United Kingdom
Countries
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Other Identifiers
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IRBN972020/CHUSTE
Identifier Type: OTHER
Identifier Source: secondary_id
20CH129
Identifier Type: -
Identifier Source: org_study_id
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