Arthritis, RheumatoidStress-PRNCT03550833
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 of Arthritis, Rheumatoid and Stress Disorder, run by University Hospital, Bordeaux at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Stress Disorder
- What is being tested?
- Questionnaire and blood sample
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 152 participants
- Where
- 5 sitesFrance
- Study dates
- 13 Jun 2018to 4 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
Who may be able to join
- 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
- 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
Who cannot join
- Pregnant or breastfeeding women
- Patient who refuse to participate.
- Control :
- Pregnant or breastfeeding women
- Patient who refuse to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Bordeaux - service de rhumatologie
Bordeaux
CH de Dax - service de rhumatologie
Dax
Hôpital Suburbain du Bouscat
Le Bouscat
CH de Libourne - service de rhumatologie
Libourne
CH de Pau - service de rhumatologie
Pau
About this study
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.
- Conditions
- Arthritis, Rheumatoid, Stress Disorder
- Being tested
- Questionnaire, blood sample
- Keywords
- Rheumatoid arthritis, Stress
- Medical subject headings
- Arthritis, Rheumatoid, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
blood sampleBiological
7 ml whole blood for Peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis patients | patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years Receives: Behavioral: Questionnaire; Biological: blood sample | |
| control patients | patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…) Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life events calculated over the year preceding the onset of PR symptoms
Social Readjustment Rating Scale (SRRS)
Measured: At inclusion (day 0)
Secondary outcomes (10)
Perceived stress
Perceived Stress Scale (PSS)
Measured: At inclusion (day 0)
Perceived control
Multidimensional Health Locus of Control Scale (MHLCS)
Measured: At inclusion (day 0)
Perceived social support
Social Support Questionnaire (SSQ)
Measured: At inclusion (day 0)
State Anxiety
State-Trait Anxiety Inventory (STAI-Y-A)
Measured: At inclusion (day 0)
Coping
Ways of Coping Checklist Scale (WCC)
Measured: At inclusion (day 0)
Cytokine levels in RA patients sera
Measured: 12 months from baseline
Correlation between cytokine levels and RA activity
Measured: 12 months from baseline
Correlation between cytokine levels and stress for RA patients
Measured: 12 months from baseline
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.
Measured: 12 months from baseline
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
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start13 Jun 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry SCHAEVERBEKE, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550833
- Sponsor's protocol ID
- CHUBX 2018/01
- Acronym
- Stress-PR
- Status last verified
- Sep 2019
- First submitted
- 28 May 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
- ClinicalTrials.gov ID
- NCT03550833
- Acronym / sponsor ID
- Stress-PR / CHUBX 2018/01
- Conditions
- Arthritis, Rheumatoid, Stress Disorder
- Keywords
- Rheumatoid arthritis, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis patients | – | Behavioral: Questionnaire, Biological: blood samplepatients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years |
| control patients | – | Behavioral: Questionnairepatients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
Key inclusion criteria (8 listed)
- 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
- patients aged over 18 years old
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Patient who refuse to participate.
- Pregnant or breastfeeding women
- Patient who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | Rheumatoid Arthritis patients, control patients |
| blood sample7 ml whole blood for Peripheral blood | Biological | Rheumatoid Arthritis patients |
Primary outcome
Life events calculated over the year preceding the onset of PR symptoms
Time frame: At inclusion (day 0)
Social Readjustment Rating Scale (SRRS)
10 secondary outcomes
Perceived stress
Time frame: At inclusion (day 0)
Perceived control
Time frame: At inclusion (day 0)
Perceived social support
Time frame: At inclusion (day 0)
State Anxiety
Time frame: At inclusion (day 0)
Coping
Time frame: At inclusion (day 0)
Cytokine levels in RA patients sera
Time frame: 12 months from baseline
Correlation between cytokine levels and RA activity
Time frame: 12 months from baseline
Correlation between cytokine levels and stress for RA patients
Time frame: 12 months from baseline
Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire
Time frame: 12 months from baseline
Characterization of neuropathic pain for RA patients evalued by Neuropathic Pain Symptom Inventory questionnaire
Time frame: 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry SCHAEVERBEKE, Prof principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Stress Disorder, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life events calculated over the year preceding the onset of PR symptoms (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.