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

Completed

• Conditions: Arthritis, Rheumatoid; Stress Disorder
• Interventions: Behavioral: Questionnaire; Biological: blood sample

• Registration Number: NCT03550833
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-05-28
• Study First Posted: 2018-06-08
• Study Start: 2018-06-13
• Primary Completion: 2019-07-04
• Study Completion: 2019-07-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis patients	Questionnaire	patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
Rheumatoid Arthritis patients	blood sample	patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
control patients	Questionnaire	patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration...)

Primary Outcome Measures

Name	Time	Method
Life events calculated over the year preceding the onset of PR symptoms	At inclusion (day 0)	Social Readjustment Rating Scale (SRRS)

Secondary Outcome Measures

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

Trial Locations

Locations (5)

CHU de Bordeaux - service de rhumatologie; 🇫🇷 Bordeaux, France

Hôpital Suburbain du Bouscat; 🇫🇷 Le Bouscat, France

CH de Libourne - service de rhumatologie; 🇫🇷 Libourne, France

CH de Dax - service de rhumatologie; 🇫🇷 Dax, France

CH de Pau - service de rhumatologie; 🇫🇷 Pau, France