NCT04491071

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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	Background questionnaire	questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
DIAGNOSTIC_TEST	Impact of COVID-19 questionnaire	status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)
DIAGNOSTIC_TEST	Confinement and Communication During the COVID-19 Pandemic	know the experience of containment and isolation during the pandemic
DIAGNOSTIC_TEST	Mental Health questionnaire	welfare effect
DIAGNOSTIC_TEST	Patient Health Questionnaire (PHQ-9)	assess depression during the pandemic
DIAGNOSTIC_TEST	Post Traumatic Stress Disorder questionnaire (PTSD-8)	Assessing the trauma of subjects during the pandemic
DIAGNOSTIC_TEST	Experiences in Close Relationship Scale questionnaire (ECR-S)	Measuring social ties and attachment of subjects

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2020-07-29
• Last updated: 2023-04-27

Locations

2 sites across 2 countries: France, United Kingdom