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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Rheumatic Fever, Mental Disorder

Intervention / Treatment
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* Behavioral: Questionnaire
* Biological: blood sample and salivary sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient affected by a chronic inflammatory rheumatism<br>patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…), | Behavioral: Questionnaire<br>* 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)<br>Biological: blood sample and salivary sample<br>* 10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.<br>|
| Active Comparator: Controls<br>patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period | Behavioral: Questionnaire<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, chronic inflammatory rheumatism, stress, Patient reported outcomes