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CompletedNCT03550833Stress-PRUpdated Sep 12, 2019

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

An observational study in Arthritis, Rheumatoid and Stress Disorder, sponsored by University Hospital, Bordeaux. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
152
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arthritis, Rheumatoid
  • Stress Disorder

Keywords

  • Rheumatoid arthritis
  • Stress
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 152 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
152 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Rheumatoid Arthritis patients

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

    Behavioral: Questionnaire · Biological: blood sample

  • control patients

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

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    Questionnaire

  • Biologicalblood sample

    7 ml whole blood for Peripheral blood

06

What researchers measure

Primary outcomes

  1. Life events calculated over the year preceding the onset of PR symptoms

    Social Readjustment Rating Scale (SRRS)

    Time frame: At inclusion (day 0)

Secondary outcomes

  1. Perceived stress

    Perceived Stress Scale (PSS)

    Time frame: At inclusion (day 0)

  2. Perceived control

    Multidimensional Health Locus of Control Scale (MHLCS)

    Time frame: At inclusion (day 0)

  3. Perceived social support

    Social Support Questionnaire (SSQ)

    Time frame: At inclusion (day 0)

  4. State Anxiety

    State-Trait Anxiety Inventory (STAI-Y-A)

    Time frame: At inclusion (day 0)

  5. Coping

    Ways of Coping Checklist Scale (WCC)

    Time frame: At inclusion (day 0)

  6. Cytokine levels in RA patients sera

    Time frame: 12 months from baseline

  7. Correlation between cytokine levels and RA activity

    Time frame: 12 months from baseline

  8. Correlation between cytokine levels and stress for RA patients

    Time frame: 12 months from baseline

  9. 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.

    Time frame: 12 months from baseline

  10. 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

    Time frame: 12 months from baseline

07

Study locations

5 sites
  • CHU de Bordeaux - service de rhumatologie
    Bordeaux, France
  • CH de Dax - service de rhumatologie
    Dax, France
  • Hôpital Suburbain du Bouscat
    Le Bouscat, France
  • CH de Libourne - service de rhumatologie
    Libourne, France
  • CH de Pau - service de rhumatologie
    Pau, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03550833
Responsible party
Sponsor
First posted
Jun 8, 2018
Start date
Jun 13, 2018
Primary completion
Jul 4, 2019
Completion
Jul 4, 2019
Last update
Sep 12, 2019

Study contacts

Thierry SCHAEVERBEKE, Prof
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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