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

NCT ID: NCT04798053

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2022-12-09

Brief Summary

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.

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.

Conditions

Covid19; Rheumatic Fever; Mental Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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…),

Group Type: EXPERIMENTAL

Questionnaire

Intervention Type: BEHAVIORAL

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)

blood sample and salivary sample

Intervention Type: BIOLOGICAL

10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.

Controls

patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period

Group Type: ACTIVE_COMPARATOR

Questionnaire

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: BEHAVIORAL

blood sample and salivary sample

10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 :

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societe Francaise de Rhumatologie

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry SCHAEVERBEKE, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux - service de rhumatologie

Bordeaux, , France

AP-HP - Hopital Henri Mondor - service de rhumatologie

Créteil, , France

CHRU de Lille - Service de rhumatologie

Lille, , France

CHU de Montpellier - service de rhumatologie

Montpellier, , France

AP-HP - Hopital Cochin - service de rhumatologie

Paris, , France

CHU de Saint-Etienne - service de rhumatologie

Saint-Etienne, , France

CHU de Toulouse - service de rhumatologie

Toulouse, , France

Countries

France

Other Identifiers

CHUBX 2020/36

Identifier Type: -

Identifier Source: org_study_id