Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients (EMOPTION)

Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

Study Overview

• Status: Completed
• Conditions: Covid19; Rheumatic Fever; Mental Disorder
• Intervention / Treatment: Behavioral: Questionnaire; Biological: blood sample and salivary sample

Detailed Description

The previous H1N1 and SRAS-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia… The French COCONEL study during the COVID pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears.

Stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. The aim of this study is therefore to evaluate the psychological impact of COVID-19 pandemic on chronic inflammatory rheumatism (CIR) affected patients.

A case-control prospective multicentric study will be performed on 212 CIR patients versus 106 controls to compare the stress level in each group. Patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on CIR evolution during a 6-months follow-up period. An ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas BARNETCHE, PhD; Email: thomas.barnetche@chu-bordeaux.fr
• Study Contact Backup: Name: Thierry SCHAEVERBEKE, Prof; Phone Number: +33 (0)556795556; Email: thierry.schaeverbeke@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux - service de rhumatologie
  • Créteil, France
    • AP-HP - Hopital Henri Mondor - service de rhumatologie
  • Lille, France
    • CHRU de Lille - Service de rhumatologie
  • Montpellier, France
    • CHU de Montpellier - service de rhumatologie
  • Paris, France
    • AP-HP - Hôpital Cochin - service de rhumatologie
  • Saint-Étienne, France
    • CHU de Saint-Etienne - service de rhumatologie
  • Toulouse, France
    • CHU de Toulouse - service de rhumatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For the cases:

Inclusion Criteria:

• adult patient (age over 18 years old)
• patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…)
• patient without any language difficulty
• affiliated to an health insurance system
• and who agree to participate in the study

For controls :

Inclusion Criteria:

• adult patient (age over 18 years ol
• patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period,
• patient without any language difficulty,
• affiliated to an health insurance system,
• and who agree to participate in the study.

For cases and controls :

Exclusion Criteria:

• pregnant or lactating patient
• psychiatric patient
• patient under guardianship or other legal protection regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient affected by a chronic inflammatory rheumatism; patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…),	Behavioral: Questionnaire; 14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire); Biological: blood sample and salivary sample; 10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
Active Comparator: Controls; patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period	Behavioral: Questionnaire; 14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion	that varies between 10 and 50 with higher values mean greater difficulties to deal with stress	At inclusion (day 0), 3 months and 6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)	that varies between 0 and 27 with higher values mean greater severity of depression	At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire	that varies between 20 and 80 with higher values mean higher levels of anxiety	At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire	that varies between 17 and 85 with higher values mean greater intensity of stress disorder	At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).		At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)	that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity.	At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)	that varies between 10 and 50 with higher values mean greater difficulties to deal with stress	At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)	that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity	At inclusion (day 0), 3 months and 6 months after inclusion
Levels of pro-inflammatory cytokines in sera of CIR patients	TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter.	At inclusion (day 0) and 6 months after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Societe Francaise de Rhumatologie
• Investigators: Principal Investigator: Thierry SCHAEVERBEKE, Prof, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Covid19; stress; chronic inflammatory rheumatism
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; COVID-19; Mental Disorders; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever
• Other Study ID Numbers: CHUBX 2020/36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No