Covid19EMOPTIONNCT04798053
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
A study testing Questionnaire and blood sample and salivary sample in people with Covid19 and Rheumatic Fever, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Rheumatic Fever, Mental Disorder
- What is being tested?
- Questionnaire and blood sample and salivary sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 7 sitesFrance
- Study dates
- 8 Apr 2021to 9 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- adult patient (age over 18 years old)
- patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…)
- patient without any language difficulty
- affiliated to an health insurance system
- and who agree to participate in the study
- For controls :
Show all 12Show fewer
- adult patient (age over 18 years ol
- patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period,
- patient without any language difficulty,
- affiliated to an health insurance system,
- and who agree to participate in the study.
- For cases and controls :
Who cannot join
- pregnant or lactating patient
- psychiatric patient
- patient under guardianship or other legal protection regimen.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux - service de rhumatologie
Bordeaux
AP-HP - Hopital Henri Mondor - service de rhumatologie
Créteil
CHRU de Lille - Service de rhumatologie
Lille
CHU de Montpellier - service de rhumatologie
Montpellier
AP-HP - Hopital Cochin - service de rhumatologie
Paris
CHU de Saint-Etienne - service de rhumatologie
Saint-Etienne
CHU de Toulouse - service de rhumatologie
Toulouse
About this study
Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.
Read the detailed description
The previous H1N1 and SRAS-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia… The French COCONEL study during the COVID pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears.
Stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. The aim of this study is therefore to evaluate the psychological impact of COVID-19 pandemic on chronic inflammatory rheumatism (CIR) affected patients.
A case-control prospective multicentric study will be performed on 212 CIR patients versus 106 controls to compare the stress level in each group. Patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on CIR evolution during a 6-months follow-up period. An ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.
- Conditions
- Covid19, Rheumatic Fever, Mental Disorder
- Being tested
- Questionnaire, blood sample and salivary sample
- Keywords
- Covid19, chronic inflammatory rheumatism, stress, Patient reported outcomes
- Medical subject headings
- COVID-19, Rheumatic Fever, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire)
blood sample and salivary sampleBiological
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
| Study group | Role | What they receive |
|---|---|---|
| Patient affected by a chronic inflammatory rheumatism | Experimental | patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…), Receives: Behavioral: Questionnaire; Biological: blood sample and salivary sample |
| Controls | Active comparator | patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Secondary outcomes (11)
Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)
that varies between 0 and 27 with higher values mean greater severity of depression
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire
that varies between 20 and 80 with higher values mean higher levels of anxiety
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire
that varies between 17 and 85 with higher values mean greater intensity of stress disorder
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity.
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity
Measured: At inclusion (day 0), 3 months and 6 months after inclusion
Levels of pro-inflammatory cytokines in sera of CIR patients
TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter.
Measured: At inclusion (day 0) and 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start8 Apr 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Responsible party
- Sponsor
- Investigators
- Thierry SCHAEVERBEKE, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798053
- Sponsor's protocol ID
- CHUBX 2020/36
- Other IDs
- 2021-A00095-36
- Acronym
- EMOPTION
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2021
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
- ClinicalTrials.gov ID
- NCT04798053
- Acronym / sponsor ID
- EMOPTION / CHUBX 2020/36
- Conditions
- Covid19, Rheumatic Fever, Mental Disorder
- Keywords
- Covid19, chronic inflammatory rheumatism, stress, Patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 15 Mar 2021 (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.
Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.
Detailed description
The previous H1N1 and SRAS-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia… The French COCONEL study during the COVID pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears.
Stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. The aim of this study is therefore to evaluate the psychological impact of COVID-19 pandemic on chronic inflammatory rheumatism (CIR) affected patients.
A case-control prospective multicentric study will be performed on 212 CIR patients versus 106 controls to compare the stress level in each group. Patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on CIR evolution during a 6-months follow-up period. An ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient affected by a chronic inflammatory rheumatism | Experimental | Behavioral: Questionnaire, Biological: blood sample and salivary samplepatient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…), |
| Controls | Active comparator | Behavioral: Questionnairepatient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- adult patient (age over 18 years old)
- patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…)
- patient without any language difficulty
- affiliated to an health insurance system
- and who agree to participate in the study
Key exclusion criteria (3 listed)
- pregnant or lactating patient
- psychiatric patient
- patient under guardianship or other legal protection regimen.
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 |
|---|---|---|
| Questionnaire14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire) | Behavioural | Controls, Patient affected by a chronic inflammatory rheumatism |
| blood sample and salivary sample10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases. | Biological | Patient affected by a chronic inflammatory rheumatism |
Primary outcome
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
11 secondary outcomes
Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
Levels of pro-inflammatory cytokines in sera of CIR patients
Time frame: At inclusion (day 0) and 6 months after inclusion
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 8 Jun 2026.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and blood sample and salivary sample in people with Covid19 and Rheumatic Fever, run by University Hospital, Bordeaux at 7 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 12 inclusion and 3 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion (time frame: At inclusion (day 0), 3 months and 6 months after inclusion). 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 8 Jun 2026.