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

Covid19 Clinical Trial

— EMOPTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798053
• Other study ID #: CHUBX 2020/36
• Status: Completed
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: December 9, 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of such diseases.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Covid19
• Mental Disorder
• Mental Disorders
• Rheumatic Diseases
• Rheumatic Fever

Intervention

Behavioral:
• 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)

Biological:
• blood sample and salivary sample
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de rhumatologie	Bordeaux
France	AP-HP - Hopital Henri Mondor - service de rhumatologie	Créteil
France	CHRU de Lille - Service de rhumatologie	Lille
France	CHU de Montpellier - service de rhumatologie	Montpellier
France	AP-HP - Hopital Cochin - service de rhumatologie	Paris
France	CHU de Saint-Etienne - service de rhumatologie	Saint-Étienne
France	CHU de Toulouse - service de rhumatologie	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Societe Francaise de Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)		At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).		At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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.	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	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	At inclusion (day 0), 3 months and 6 months after inclusion
Secondary	Levels of pro-inflammatory cytokines in sera of CIR patients	TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter.	At inclusion (day 0) and 6 months after inclusion