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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03550833
Acronym
Stress-PR
Enrollment
152
Registered
2018-06-08
Start date
2018-06-13
Completion date
2019-07-04
Last updated
2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid, Stress Disorder

Keywords

Rheumatoid arthritis, Stress

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.

Interventions

BEHAVIORALQuestionnaire

Questionnaire

BIOLOGICALblood sample

7 ml whole blood for Peripheral blood

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Life events calculated over the year preceding the onset of PR symptomsAt inclusion (day 0)Social Readjustment Rating Scale (SRRS)

Secondary

MeasureTime frameDescription
Correlation between cytokine levels and RA activity12 months from baseline
Correlation between cytokine levels and stress for RA patients12 months from baseline
State AnxietyAt inclusion (day 0)State-Trait Anxiety Inventory (STAI-Y-A)
CopingAt inclusion (day 0)Ways of Coping Checklist Scale (WCC)
Cytokine levels in RA patients sera12 months from baseline
Perceived controlAt inclusion (day 0)Multidimensional Health Locus of Control Scale (MHLCS)
Perceived social supportAt inclusion (day 0)Social Support Questionnaire (SSQ)
Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire12 months from baselinedouleur-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 questionnaire12 months from baselineNeuropathic Pain Symptom Inventory questionnaire with 12 items to complete, providing for each item the presence (or the absence) of several pain symptoms
Perceived stressAt inclusion (day 0)Perceived Stress Scale (PSS)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026