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

NCT ID: NCT03550833

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2019-07-04

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid Stress Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatoid Arthritis patients

patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire

blood sample

Intervention Type BIOLOGICAL

7 ml whole blood for Peripheral blood

control patients

patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…)

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire

Interventions

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Questionnaire

Questionnaire

Intervention Type BEHAVIORAL

blood sample

7 ml whole blood for Peripheral blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


* 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.

Control :


* Pregnant or breastfeeding women
* Patient who refuse to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry SCHAEVERBEKE, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux - service de rhumatologie

Bordeaux, , France

Site Status

CH de Dax - service de rhumatologie

Dax, , France

Site Status

Hôpital Suburbain du Bouscat

Le Bouscat, , France

Site Status

CH de Libourne - service de rhumatologie

Libourne, , France

Site Status

CH de Pau - service de rhumatologie

Pau, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2018/01

Identifier Type: -

Identifier Source: org_study_id

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