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Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population (PsyConfPop)

28. desember 2020 oppdatert av: University Hospital, Montpellier

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

Ukjent

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

Observasjonsmessig

Registrering (Forventet)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Montpellier, Frankrike, 34295
        • Rekruttering
        • University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Adults who agree to participate by answering the questionnaires

Beskrivelse

Inclusion criteria:

- age> 18

Exclusion criteria:

- protective measure (curatorship, guardianship)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Emilie OLIE, MD PhD, University Hospital, Montpellier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2020

Primær fullføring (Forventet)

1. desember 2021

Studiet fullført (Forventet)

30. desember 2021

Datoer for studieregistrering

Først innsendt

30. april 2020

Først innsendt som oppfylte QC-kriteriene

30. april 2020

Først lagt ut (Faktiske)

5. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RECHMPL20_0197

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IPD-planbeskrivelse

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