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

University Hospital of Bordeaux

Status: Completed

Conditions: Mental Disorder; Covid19; Rheumatic Fever

Treatments: Biological: blood sample and salivary sample; Behavioral: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT04798053

CHUBX 2020/36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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259 participants in 2 patient groups

Patient affected by a chronic inflammatory rheumatism

Experimental group

Description:

patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma...),

Treatment:

Biological: blood sample and salivary sample

Behavioral: Questionnaire

Controls

Active Comparator group

Description:

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

Treatment:

Behavioral: Questionnaire