Clinical trial NCT03550833: Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
Official title: Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Stress Disorder
Keywords: Rheumatoid arthritis
Stress
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years

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.

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

Primary outcomes:
measure: Life events calculated over the year preceding the onset of PR symptoms
timeFrame: At inclusion (day 0)
Secondary outcomes:
measure: Perceived stress
timeFrame: At inclusion (day 0)
measure: Perceived control
timeFrame: At inclusion (day 0)
measure: Perceived social support
timeFrame: At inclusion (day 0)
measure: State Anxiety
timeFrame: At inclusion (day 0)
measure: Coping
timeFrame: At inclusion (day 0)
measure: Cytokine levels in RA patients sera
timeFrame: 12 months from baseline
measure: Correlation between cytokine levels and RA activity
timeFrame: 12 months from baseline
measure: Correlation between cytokine levels and stress for RA patients
timeFrame: 12 months from baseline
measure: Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire
timeFrame: 12 months from baseline
measure: Characterization of neuropathic pain for RA patients evalued by Neuropathic Pain Symptom Inventory questionnaire
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de rhumatologie
city: Dax
country: France
facility: CH de Dax - service de rhumatologie
city: Le Bouscat
country: France
facility: Hôpital Suburbain du Bouscat
city: Libourne
country: France
facility: CH de Libourne - service de rhumatologie
city: Pau
country: France
facility: CH de Pau - service de rhumatologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Thierry SCHAEVERBEKE, Prof
role: PRINCIPAL_INVESTIGATOR
References: