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

NCT04491071 | Terminated

• 2 other identifiers: 20CH129IRBN972020/CHUSTE
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

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).

Conditions

Stress Disorder

Keywords

COVID-19; Stress; Effects on Immunity; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Results of the Mental Health questionnaire

  5 minutes

• Results of the Patient Health Questionnaire (PHQ-9)

  5 minutes

• Results of the Post Traumatic Stress Disorder (PTSD-8)

  5 minutes

• Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)

  5 minutes

Study Arms (1)

Volunteers

volunteers over 18 years of age

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)

Interventions

Generalized Anxiety Disorder-7 (GAD 7) DIAGNOSTIC_TEST

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.

Volunteers

Background questionnaire DIAGNOSTIC_TEST

questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants

Volunteers

Impact of COVID-19 questionnaire DIAGNOSTIC_TEST

status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)

Volunteers

Confinement and Communication During the COVID-19 Pandemic DIAGNOSTIC_TEST

know the experience of containment and isolation during the pandemic

Volunteers

Mental Health questionnaire DIAGNOSTIC_TEST

welfare effect

Volunteers

Patient Health Questionnaire (PHQ-9) DIAGNOSTIC_TEST

assess depression during the pandemic

Volunteers

Post Traumatic Stress Disorder questionnaire (PTSD-8) DIAGNOSTIC_TEST

Assessing the trauma of subjects during the pandemic

Volunteers

Experiences in Close Relationship Scale questionnaire (ECR-S) DIAGNOSTIC_TEST

Measuring social ties and attachment of subjects

Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Health Volunteers

You may qualify if:

• Adult volunteer who agreed to answer the questionnaires
• Age ≥ 18 years old
• Adult affiliated or having a duty to a social security scheme

You may not qualify if:

• Children under 18 years old
• Inability to understand information letter, consent, or to use online questionnaire

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42270, France

Location

Centre de Recherche et d'Innovation Clinique

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic; COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Claude LAMBERT, MD PhD HDR

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 29, 2020
• Study Start: October 22, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (1)