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Completed

NCT Number: NCT03550833

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - service de rhumatologie, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

Questionnaire

Blood sample

Biological

7 ml whole blood for Peripheral blood

Primary outcomes

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

    Time frame: At inclusion (day 0)

    Social Readjustment Rating Scale (SRRS)

Secondary outcomes

  1. Perceived stress

    Time frame: At inclusion (day 0)

    Perceived Stress Scale (PSS)

  2. Perceived control

    Time frame: At inclusion (day 0)

    Multidimensional Health Locus of Control Scale (MHLCS)

  3. Perceived social support

    Time frame: At inclusion (day 0)

    Social Support Questionnaire (SSQ)

  4. State Anxiety

    Time frame: At inclusion (day 0)

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

  5. Coping

    Time frame: At inclusion (day 0)

    Ways of Coping Checklist Scale (WCC)

  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

    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.

  10. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: Stress-PR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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