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

September 10, 2019 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux - service de rhumatologie
      • Dax, France
        • CH de Dax - service de rhumatologie
      • Le Bouscat, France
        • Hopital Suburbain Du Bouscat
      • Libourne, France
        • CH de Libourne - service de rhumatologie
      • Pau, France
        • CH de Pau - service de rhumatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid Arthritis patients
patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
Behavioral: Questionnaire
Questionnaire
Biological: blood sample
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…)
Behavioral: Questionnaire
Questionnaire

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
Time Frame: At inclusion (day 0)
Social Readjustment Rating Scale (SRRS)
At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: At inclusion (day 0)
Perceived Stress Scale (PSS)
At inclusion (day 0)
Perceived control
Time Frame: At inclusion (day 0)
Multidimensional Health Locus of Control Scale (MHLCS)
At inclusion (day 0)
Perceived social support
Time Frame: At inclusion (day 0)
Social Support Questionnaire (SSQ)
At inclusion (day 0)
State Anxiety
Time Frame: At inclusion (day 0)
State-Trait Anxiety Inventory (STAI-Y-A)
At inclusion (day 0)
Coping
Time Frame: At inclusion (day 0)
Ways of Coping Checklist Scale (WCC)
At inclusion (day 0)
Cytokine levels in RA patients sera
Time Frame: 12 months from baseline
12 months from baseline
Correlation between cytokine levels and RA activity
Time Frame: 12 months from baseline
12 months from baseline
Correlation between cytokine levels and stress for RA patients
Time Frame: 12 months from baseline
12 months from baseline
Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire
Time Frame: 12 months from baseline
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
Time Frame: 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
12 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Thierry SCHAEVERBEKE, Prof, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

July 4, 2019

Study Completion (Actual)

July 4, 2019

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2018/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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