Clinical trial NCT04491071: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
Official title: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Disorder
Keywords: COVID-19
Stress
Effects on Immunity
Anxiety
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Health Volunteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: Results of the Generalized Anxiety Disorder (GAD-7)
timeFrame: 5 Minutes
Secondary outcomes:
measure: Results of the Mental Health questionnaire
timeFrame: 5 minutes
measure: Results of the Patient Health Questionnaire (PHQ-9)
timeFrame: 5 minutes
measure: Results of the Post Traumatic Stress Disorder (PTSD-8)
timeFrame: 5 minutes
measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Glasgow
country: United Kingdom
facility: Centre de Recherche et d'Innovation Clinique
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Claude LAMBERT, MD PhD HDR
role: PRINCIPAL_INVESTIGATOR
References: