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

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).

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42270
    • Centre Hospitalier Universitaire de Saint-Etienne
• United Kingdom
  • Glasgow, United Kingdom
    • Centre de Recherche et d'Innovation Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Health Volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Volunteers; volunteers over 18 years of age

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of the Generalized Anxiety Disorder (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. Scored between 0-21: Cut offs: 0-4 = None; 5-9 = Mild anxiety; 10-14 = Moderate anxiety; 15-21 = Severe anxiety	5 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of the Mental Health questionnaire	Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.	5 minutes
Results of the Patient Health Questionnaire (PHQ-9)	assess 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	5 minutes
Results of the Post Traumatic Stress Disorder (PTSD-8)	Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.	5 minutes
Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)	Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.	5 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Claude LAMBERT, MD PhD HDR, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Stress; COVID-19; Effects on Immunity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20CH129; IRBN972020/CHUSTE (Other Identifier: Comité d'éthique)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No