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Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population

Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04397835
Acronym
PSYCOV-CV
Enrollment
534
Registered
2020-05-21
Start date
2020-04-17
Completion date
2021-07-17
Last updated
2022-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, COVID-19, Depression, Stress

Keywords

quarantine, psychological impact, cardiovascular disease, general population

Brief summary

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

Detailed description

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk. A prospective epidemiological observational cohort study will be carried out (in French general population aged 50 to 89 years) with data collection by telephone interviews (in agreement with the context of quarantine). The telephone interviews will be carried out during quarantine (V1), in the month following the end of quarantine (V2) and then, at 6 (V3) and 12 (V4) months. At baseline, the questionnaire will focus on socio-demographic and contextual characteristics related to the COVID-19 outbreak, medical history, cardiovascular risk factors and treatments, anxiety and depression scales. Next (after the quarantine), the questionnaire will focus on the evolution of cardiovascular risk factors and the occurrence of acute cardiovascular events, the evolution of treatments and post-traumatic stress, anxiety or depression scales. The assessment of risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors of the worsening of cardiovascular risk will be based on mixed logistic regression.

Interventions

None listed

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* All participants of the MONALISA survey residing in south-western France (Toulouse area).

Exclusion criteria

* Opposition to participate in this new survey * Pregnancy or breastfeeding * Subject under guardianship, curatorship or safeguard of justice * Lack of health insurance coverage

Design outcomes

Primary

MeasureTime frameDescription
worsening of cardiovascular risk (food balance)at 1, 6 and 12 monthThe worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of alteration of the food balance
worsening of cardiovascular risk (physical activity)at 1, 6 and 12 monthThe worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: \- reduction in the level of physical activity
worsening of cardiovascular risk (treatments)at 1, 6 and 12 monthThe worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: \- introduction or increase of antihypertensive, lipid-lowering or hypoglycaemic drug treatment on the prescription
worsening of cardiovascular risk (smoking consumption)at 1, 6 and 12 monthThe worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of increased smoking consumption
worsening of cardiovascular risk (weight gain)at 1, 6 and 12 monthThe worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of weight gain

Secondary

MeasureTime frameDescription
psychological impact of the quarantine on healthat 1, 6 and 12 monthPatient Health Questionnaire (PHQ-9) : Kroenke, K., Spitzer, R. L. et Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med, 16(9), 606-613.
psychological impact of the quarantine on stressat 1, 6 and 12 monthImpact of Event Scale - Revised (IES-R) : * Weiss, D. S. et Marmar, C. R. (1996). The Impact of Event Scale-Revised. Dans J. P. Wilson et T. M. Keane (dir.). Assessing psychological trauma and PTSD. New York : Guildford Press. * Brunet, A., St-Hilaire, A., Jehel, L. et King, S. (2003). Validation of a French Version of the Impact of Event Scale-Revised.
psychological impact of the quarantine on anxietyat 1, 6 and 12 monthGeneralized Anxiety Disorder (GAD-7) : Spitzer, R. L., Kroenke, K., Williams, J. B. W. et Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Archives of Internal Medicine, 166(10), 1092-1097.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026