- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Montpellier, Francie, 34295
- Nábor
- University Hospital
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Kontakt:
- Catherine GENTY, MD
- Telefonní číslo: +33 4 67 99 61 45 75
- E-mail: c-genty@chu-montpellier.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion criteria:
- age> 18
Exclusion criteria:
- protective measure (curatorship, guardianship)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Confined patients
General population
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Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Depressive Symptomatology
Časové okno: during confinement
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depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
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during confinement
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Depressive Symptomatology
Časové okno: post-confinement : 15 days, 3 months, 6 months
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depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
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post-confinement : 15 days, 3 months, 6 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Psychological pain
Časové okno: during confinement
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Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
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during confinement
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sleep
Časové okno: during confinement
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quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
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during confinement
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sleep
Časové okno: post-confinement (15 days, 3 months, 6 months)
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quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
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post-confinement (15 days, 3 months, 6 months)
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anxiety
Časové okno: during confinement
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anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
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during confinement
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anxiety
Časové okno: post-confinement (15 days, 3 months, 6 months)
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anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
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post-confinement (15 days, 3 months, 6 months)
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psychological pain
Časové okno: post-confinement (15 days, 3 months, 6 months)
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psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
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post-confinement (15 days, 3 months, 6 months)
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physical pain
Časové okno: during confinement
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psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
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during confinement
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physical pain
Časové okno: post-confinement (15 days, 3 months, 6 months)
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psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)
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post-confinement (15 days, 3 months, 6 months)
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anger
Časové okno: during confinement
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staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
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during confinement
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anger
Časové okno: post-confinement (15 days, 3 months, 6 months)
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staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
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post-confinement (15 days, 3 months, 6 months)
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Stressful Event Impact
Časové okno: during confinement
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Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45) ) |
during confinement
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Stressful Event Impact
Časové okno: 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)
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post-confinement (15 days, 3 months, 6 months)
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Use of psychotropic drugs
Časové okno: during confinement
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Number of patients declaring an increase of psychotropic drug use
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during confinement
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Use of psychotropic drugs
Časové okno: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of psychotropic drug use
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post-confinement (15 days, 3 months, 6 months)
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Tobacco consumption
Časové okno: 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
Časové okno: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of tobacco consumption
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post-confinement (15 days, 3 months, 6 months)
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alcohol consumption
Časové okno: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of alcohol consumption
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post-confinement (15 days, 3 months, 6 months)
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alcohol consumption
Časové okno: confinement
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Number of patients declaring an increase of alcohol consumption
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confinement
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Illicit substances consumption
Časové okno: confinement
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Number of patients declaring an increase of illicit substances consumption
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confinement
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Illicit substances consumption
Časové okno: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of illicit substances consumption
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post-confinement (15 days, 3 months, 6 months)
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orientation of life
Časové okno: confinement
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Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
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confinement
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orientation of life
Časové okno: 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
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post-confinement (15 days, 3 months, 6 months)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emilie Olie, MD PhD, University Hospital, Montpellier
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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