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

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ClinicalTrials.gov Identifier: NCT04491071
Recruitment Status : Not yet recruiting
First Posted : July 29, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Stress Disorder 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.

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Study Type : Observational
Estimated Enrollment : 405 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Results of the Mental Health questionnaire [ Time Frame: 5 minutes ]
    Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.

  2. Results of the Patient Health Questionnaire (PHQ-9) [ Time Frame: 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

  3. Results of the Post Traumatic Stress Disorder (PTSD-8) [ Time Frame: 5 minutes ]
    Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.

  4. Results of the Experiences in Close Relationship Scale questionnaire (ECR-S) [ Time Frame: 5 minutes ]
    Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Health Volunteers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491071


Contacts
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Contact: Claude LAMBERT, MD PhD HDR (0)477120513 ext +33 claude.lambert@chu-st-etienne.fr
Contact: Fleur PETIT, CRA (0)477120826 fleur.petit@chu-st-etienne.fr

Locations
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France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Étienne, France, 42270
United Kingdom
Centre de Recherche et d'Innovation Clinique
Glasgow, United Kingdom
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Claude LAMBERT, MD PhD HDR CHU Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04491071    
Other Study ID Numbers: 20CH129
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
COVID-19
Stress
Effects on Immunity
Anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Stress Disorders, Traumatic
Mental Disorders
Trauma and Stressor Related Disorders