- ICH GCP
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- Essai clinique NCT04374643
Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population (PsyConfPop)
Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The main objective is to describe the psychological state during confinement (and the impact of the confinement) in a sample of the French general population.
Secondary objectives :
- to assess the evolution of psychological health between the period of confinement and post-confinement.
- to identify clinical factors modulating psychological state during confinement
It is expected to highlight :
- a link between the intensity of anxiety symptoms and the number/quality of social contacts
- a reduction of anxiety and depression symptoms in the post-confinement period.
- higher consumption of drugs during the confinement period
Self-questionnaires (Google form format) are sent by mailing lists or social networks to participants in order to complete the assessment of psychological state. A unique identifier is sent in a separate email. These assessments are performed at least once during the confinement period. It is planned to repeat them when the confinement is lifted: 15 days, 3 and 6 months after the lifting of the confinement because of the risk of developing anxiodepressive symptoms, in particular post-traumatic stressors.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Montpellier, France, 34295
- Recrutement
- University Hospital
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Contact:
- Catherine GENTY, MD
- Numéro de téléphone: +33 4 67 99 61 45 75
- E-mail: c-genty@chu-montpellier.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion criteria:
- age> 18
Exclusion criteria:
- protective measure (curatorship, guardianship)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Confined patients
General population
|
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Depressive Symptomatology
Délai: during confinement
|
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
|
during confinement
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Depressive Symptomatology
Délai: post-confinement : 15 days, 3 months, 6 months
|
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
|
post-confinement : 15 days, 3 months, 6 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Psychological pain
Délai: during confinement
|
Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
|
sleep
Délai: during confinement
|
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
|
during confinement
|
sleep
Délai: post-confinement (15 days, 3 months, 6 months)
|
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
|
post-confinement (15 days, 3 months, 6 months)
|
anxiety
Délai: during confinement
|
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
|
during confinement
|
anxiety
Délai: post-confinement (15 days, 3 months, 6 months)
|
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
|
post-confinement (15 days, 3 months, 6 months)
|
psychological pain
Délai: post-confinement (15 days, 3 months, 6 months)
|
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
post-confinement (15 days, 3 months, 6 months)
|
physical pain
Délai: during confinement
|
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
|
physical pain
Délai: post-confinement (15 days, 3 months, 6 months)
|
psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)
|
post-confinement (15 days, 3 months, 6 months)
|
anger
Délai: during confinement
|
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
|
during confinement
|
anger
Délai: post-confinement (15 days, 3 months, 6 months)
|
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
|
post-confinement (15 days, 3 months, 6 months)
|
Stressful Event Impact
Délai: during confinement
|
Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45) ) |
during confinement
|
Stressful Event Impact
Délai: post-confinement (15 days, 3 months, 6 months)
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Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45)
|
post-confinement (15 days, 3 months, 6 months)
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Use of psychotropic drugs
Délai: during confinement
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Number of patients declaring an increase of psychotropic drug use
|
during confinement
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Use of psychotropic drugs
Délai: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of psychotropic drug use
|
post-confinement (15 days, 3 months, 6 months)
|
Tobacco consumption
Délai: during confinement
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Number of patients declaring an increase of tobacco consumption
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during confinement
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Tobacco consumption
Délai: post-confinement (15 days, 3 months, 6 months)
|
Number of patients declaring an increase of tobacco consumption
|
post-confinement (15 days, 3 months, 6 months)
|
alcohol consumption
Délai: post-confinement (15 days, 3 months, 6 months)
|
Number of patients declaring an increase of alcohol consumption
|
post-confinement (15 days, 3 months, 6 months)
|
alcohol consumption
Délai: confinement
|
Number of patients declaring an increase of alcohol consumption
|
confinement
|
Illicit substances consumption
Délai: confinement
|
Number of patients declaring an increase of illicit substances consumption
|
confinement
|
Illicit substances consumption
Délai: post-confinement (15 days, 3 months, 6 months)
|
Number of patients declaring an increase of illicit substances consumption
|
post-confinement (15 days, 3 months, 6 months)
|
orientation of life
Délai: confinement
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Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
|
confinement
|
orientation of life
Délai: post-confinement (15 days, 3 months, 6 months)
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Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
|
post-confinement (15 days, 3 months, 6 months)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Emilie Olie, MD PhD, University Hospital, Montpellier
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RECHMPL20_0197
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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