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Clinical Trials/NCT04491071
NCT04491071
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne2 sites in 2 countries150 target enrollmentOctober 22, 2020
ConditionsStress Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorder
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
150
Locations
2
Primary Endpoint
Results of the Generalized Anxiety Disorder (GAD-7)
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2020
End Date
September 29, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Results of the Generalized Anxiety Disorder (GAD-7)

Time Frame: 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 Outcomes

  • Results of the Post Traumatic Stress Disorder (PTSD-8)(5 minutes)
  • Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)(5 minutes)
  • Results of the Patient Health Questionnaire (PHQ-9)(5 minutes)
  • Results of the Mental Health questionnaire(5 minutes)

Study Sites (2)

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