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Clinical trial

Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients

ID
Name
CHUBX 2020/36
Description
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.
Trial arms
Trial start
2021-04-08
Estimated PCD
2022-12-09
Trial end
2022-12-09
Status
Completed
Treatment
Questionnaire
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)
Arms:
Controls, Patient affected by a chronic inflammatory rheumatism
blood sample and salivary sample
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
Arms:
Patient affected by a chronic inflammatory rheumatism
Size
259
Primary endpoint
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
At inclusion (day 0), 3 months and 6 months after inclusion
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 259, 'type': 'ACTUAL'}}
Updated at
2023-03-02

1 organization

1 product

3 indications

Organization
University Hospital Bordeaux
Product
Blood Sample + Salivary Sample
Indication
COVID-19
Indication
rheumatic fever
Indication
Mental Illness