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

Arthritis, Rheumatoid Clinical Trial

— Stress-PR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550833
• Other study ID #: CHUBX 2018/01
• Status: Completed
• Start date: June 13, 2018
• Est. completion date: July 4, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 4, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Stress Disorder
• Stress, Psychological

Intervention

Behavioral:
• Questionnaire
Questionnaire

Biological:
• blood sample
7 ml whole blood for Peripheral blood

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life events calculated over the year preceding the onset of PR symptoms	Social Readjustment Rating Scale (SRRS)	At inclusion (day 0)
Secondary	Perceived stress	Perceived Stress Scale (PSS)	At inclusion (day 0)
Secondary	Perceived control	Multidimensional Health Locus of Control Scale (MHLCS)	At inclusion (day 0)
Secondary	Perceived social support	Social Support Questionnaire (SSQ)	At inclusion (day 0)
Secondary	State Anxiety	State-Trait Anxiety Inventory (STAI-Y-A)	At inclusion (day 0)
Secondary	Coping	Ways of Coping Checklist Scale (WCC)	At inclusion (day 0)
Secondary	Cytokine levels in RA patients sera		12 months from baseline
Secondary	Correlation between cytokine levels and RA activity		12 months from baseline
Secondary	Correlation between cytokine levels and stress for RA patients		12 months from baseline
Secondary	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.	12 months from baseline
Secondary	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	12 months from baseline