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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Stress Disorder

Treatments: Diagnostic Test: Mental Health questionnaire; Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7); Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic; Diagnostic Test: Impact of COVID-19 questionnaire; Diagnostic Test: Patient Health Questionnaire (PHQ-9); Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8); Diagnostic Test: Background questionnaire; Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S)

Study type: Observational

Funder types: Other

Identifiers

NCT04491071

20CH129

IRBN972020/CHUSTE (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Volunteers

Description:

volunteers over 18 years of age

Treatment:

Diagnostic Test: Mental Health questionnaire

Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7)

Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic

Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S)

Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8)

Diagnostic Test: Background questionnaire

Diagnostic Test: Impact of COVID-19 questionnaire

Diagnostic Test: Patient Health Questionnaire (PHQ-9)