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

Stress Disorder Clinical Trial

— SCEI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04491071
• Other study ID #: 20CH129
• Secondary ID: IRBN972020/CHUST
• Status: Terminated
• Start date: October 22, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Stress Disorder

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Étienne
United Kingdom	Centre de Recherche et d'Innovation Clinique	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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