NCT04374643

Brief Summary

Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms. From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic. Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

April 30, 2020

Last Update Submit

December 28, 2020

Conditions

Keywords

ConfinementDepressionPost traumatic stressAdults

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptomatology

    depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -\> min : 0 max : 27)

    during confinement

Secondary Outcomes (1)

  • Depressive Symptomatology

    post-confinement : 15 days, 3 months, 6 months

Other Outcomes (22)

  • Psychological pain

    during confinement

  • sleep

    during confinement

  • sleep

    post-confinement (15 days, 3 months, 6 months)

  • +19 more other outcomes

Study Arms (1)

Confined patients

General population

Other: Slef questionnaires fulfilment

Interventions

Questionnaires to assess the psychological impact of confinement and its evolution over 6 months

Confined patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults who agree to participate by answering the questionnaires

You may qualify if:

  • \- age\> 18

You may not qualify if:

  • \- protective measure (curatorship, guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

DepressionCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Emilie Olie, MD PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

April 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations