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

Terminated

• Conditions: Stress Disorder
• Interventions: 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)

• Registration Number: NCT04491071
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-29
• Study Start: 2020-10-22
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volunteers	Generalized Anxiety Disorder-7 (GAD 7)	volunteers over 18 years of age
Volunteers	Patient Health Questionnaire (PHQ-9)	volunteers over 18 years of age
Volunteers	Background questionnaire	volunteers over 18 years of age
Volunteers	Confinement and Communication During the COVID-19 Pandemic	volunteers over 18 years of age
Volunteers	Impact of COVID-19 questionnaire	volunteers over 18 years of age
Volunteers	Experiences in Close Relationship Scale questionnaire (ECR-S)	volunteers over 18 years of age
Volunteers	Mental Health questionnaire	volunteers over 18 years of age
Volunteers	Post Traumatic Stress Disorder questionnaire (PTSD-8)	volunteers over 18 years of age

Primary Outcome Measures

Name	Time	Method
Results of the Generalized Anxiety Disorder (GAD-7)	5 Minutes	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Saint-Etienne; 🇫🇷 Saint-Étienne, France

Centre de Recherche et d'Innovation Clinique; 🇬🇧 Glasgow, United Kingdom