Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheuma… (NCT04798053) | Clinical Trial Compass
CompletedNot Applicable
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
France259 participantsStarted 2021-04-08
Plain-language 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 of such diseases.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For the cases:
Inclusion Criteria:
* 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 :
Inclusion Criteria:
* 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 :
Exclusion Criteria:
* pregnant or lactating patient
* psychiatric patient
* patient under guardianship or other legal protection regimen.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at how COVID-19 social distancing affected the mental health of people with chronic inflammatory rheumatism — does my own rheumatic condition put me at similar risk for pandemic-related stress, and is that something we should be actively monitoring?
2The trial used a tool called the Perceived Stress Scale (PSS-10) to track stress levels over 6 months — is this something you could use in my regular care to check whether my mental health is being affected by living with a rheumatic condition?
3Since this study is now completed, have any results been published that might change how you approach mental health support for patients like me who have a chronic inflammatory rheumatic disease?
4The trial focused on the overlap between rheumatic disease and mental health disorders — do you think I should be seeing a mental health professional alongside my rheumatology care, especially given what studies like this are finding?
5Given that stress and mental health can affect how rheumatic diseases behave, is there anything specific you would recommend I do now to protect my mental well-being, based on what research like this is showing??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
Timeframe: At inclusion (day 0), 3 months and 6 months after inclusion