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Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491071
Acronym
SCEI
Enrollment
150
Registered
2020-07-29
Start date
2020-10-22
Completion date
2021-09-29
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorder

Keywords

COVID-19, Stress, Effects on Immunity, Anxiety

Brief 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 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.

Interventions

DIAGNOSTIC_TESTGeneralized 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.

questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants

DIAGNOSTIC_TESTImpact of COVID-19 questionnaire

status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)

DIAGNOSTIC_TESTConfinement and Communication During the COVID-19 Pandemic

know the experience of containment and isolation during the pandemic

DIAGNOSTIC_TESTMental Health questionnaire

welfare effect

DIAGNOSTIC_TESTPatient Health Questionnaire (PHQ-9)

assess depression during the pandemic

DIAGNOSTIC_TESTPost Traumatic Stress Disorder questionnaire (PTSD-8)

Assessing the trauma of subjects during the pandemic

DIAGNOSTIC_TESTExperiences in Close Relationship Scale questionnaire (ECR-S)

Measuring social ties and attachment of subjects

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult volunteer who agreed to answer the questionnaires * Age ≥ 18 years old * Adult affiliated or having a duty to a social security scheme

Exclusion criteria

* Children under 18 years old * Inability to understand information letter, consent, or to use online questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Results of the Generalized Anxiety Disorder (GAD-7)5 Minutestest 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

Secondary

MeasureTime frameDescription
Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)5 minutesMeasuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.
Results of the Mental Health questionnaire5 minutesWelfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.
Results of the Patient Health Questionnaire (PHQ-9)5 minutesassess 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
Results of the Post Traumatic Stress Disorder (PTSD-8)5 minutesAssessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.

Countries

France, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026