Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

Study Overview
=================
Brief Summary
-----------------
Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.

Detailed Description
-----------------
The physiopathology of RA is multifactorial, implicating genetic and environmental factors. Within the environmental factors, the exact role of psychological stress and life events on the onset of the disease is still under question. In clinical practice, patients usually report the occurrence of a stressing life event before the diagnosis of the disease (mourning, dismissal, divorce…). Nevertheless, literature reviews present some discrepancies and did not lead to a clear identification of the role of psychological stress in RA onset. This is mainly due to the evaluation methods of stress within those previous studies, considering stress as a unique response of the organism without taking into account personal, sociological, biological or environmental history. The aim of the study is to analyze the impact of stress on the RA onset within an integrative model, to evaluate patient assessment of the stress, and to present strategies to fix it.

Official Title
-----------------
Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

Conditions
-----------------
Arthritis, Rheumatoid, Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Questionnaire
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients RA : Inclusion Criteria: patients aged over 18 years old patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years. Speaking and understanding French language Being informed about the study and having given his oral consent Exclusion Criteria: Pregnant or breastfeeding women Patient who refuse to participate. Control : Inclusion Criteria: patients aged over 18 years old patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…) Speaking and understanding French language Being informed about the study and having given his oral consent Exclusion Criteria: Pregnant or breastfeeding women Patient who refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid Arthritis patients<br>patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years | Behavioral: Questionnaire<br>* Questionnaire<br>Biological: blood sample<br>* 7 ml whole blood for Peripheral blood<br>|
| control patients<br>patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…) | Behavioral: Questionnaire<br>* Questionnaire<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life events calculated over the year preceding the onset of PR symptoms | Social Readjustment Rating Scale (SRRS) | At inclusion (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress | Perceived Stress Scale (PSS) | At inclusion (day 0) | 
| Perceived control | Multidimensional Health Locus of Control Scale (MHLCS) | At inclusion (day 0) | 
| Perceived social support | Social Support Questionnaire (SSQ) | At inclusion (day 0) | 
| State Anxiety | State-Trait Anxiety Inventory (STAI-Y-A) | At inclusion (day 0) | 
| Coping | Ways of Coping Checklist Scale (WCC) | At inclusion (day 0) | 
| Cytokine levels in RA patients sera |  | 12 months from baseline | 
| Correlation between cytokine levels and RA activity |  | 12 months from baseline | 
| Correlation between cytokine levels and stress for RA patients |  | 12 months from baseline | 
| Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire | douleur-neuropathique 10 items questionnaire providing a score between 0 and 10, with a positive threshold value beyond 4/10. | 12 months from baseline | 
| Characterization of neuropathic pain for RA patients evalued by Neuropathic Pain Symptom Inventory questionnaire | Neuropathic Pain Symptom Inventory questionnaire with 12 items to complete, providing for each item the presence (or the absence) of several pain symptoms | 12 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, Stress