- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Montpellier, Frankrike, 34295
- Rekruttering
- University Hospital
-
Ta kontakt med:
- Catherine GENTY, MD
- Telefonnummer: +33 4 67 99 61 45 75
- E-post: c-genty@chu-montpellier.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion criteria:
- age> 18
Exclusion criteria:
- protective measure (curatorship, guardianship)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Confined patients
General population
|
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depressive Symptomatology
Tidsramme: during confinement
|
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
|
during confinement
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depressive Symptomatology
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychological pain
Tidsramme: during confinement
|
Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
|
|
sleep
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during confinement
|
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
|
|
physical pain
Tidsramme: 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
Tidsramme: during confinement
|
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
|
during confinement
|
|
anger
Tidsramme: 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
Tidsramme: during confinement
|
Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45) ) |
during confinement
|
|
Stressful Event Impact
Tidsramme: post-confinement (15 days, 3 months, 6 months)
|
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)
|
|
Use of psychotropic drugs
Tidsramme: during confinement
|
Number of patients declaring an increase of psychotropic drug use
|
during confinement
|
|
Use of psychotropic drugs
Tidsramme: post-confinement (15 days, 3 months, 6 months)
|
Number of patients declaring an increase of psychotropic drug use
|
post-confinement (15 days, 3 months, 6 months)
|
|
Tobacco consumption
Tidsramme: during confinement
|
Number of patients declaring an increase of tobacco consumption
|
during confinement
|
|
Tobacco consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: confinement
|
Number of patients declaring an increase of alcohol consumption
|
confinement
|
|
Illicit substances consumption
Tidsramme: confinement
|
Number of patients declaring an increase of illicit substances consumption
|
confinement
|
|
Illicit substances consumption
Tidsramme: 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
Tidsramme: confinement
|
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
|
confinement
|
|
orientation of life
Tidsramme: post-confinement (15 days, 3 months, 6 months)
|
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
|
post-confinement (15 days, 3 months, 6 months)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Emilie OLIE, MD PhD, University Hospital, Montpellier
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECHMPL20_0197
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .