- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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-
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Montpellier, 프랑스, 34295
- 모병
- University Hospital
-
연락하다:
- Catherine GENTY, MD
- 전화번호: +33 4 67 99 61 45 75
- 이메일: c-genty@chu-montpellier.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion criteria:
- age> 18
Exclusion criteria:
- protective measure (curatorship, guardianship)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Confined patients
General population
|
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Depressive Symptomatology
기간: during confinement
|
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
|
during confinement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Depressive Symptomatology
기간: 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)
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post-confinement : 15 days, 3 months, 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Psychological pain
기간: during confinement
|
Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
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sleep
기간: during confinement
|
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
|
during confinement
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sleep
기간: 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)
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anxiety
기간: during confinement
|
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
기간: 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)
|
post-confinement (15 days, 3 months, 6 months)
|
psychological pain
기간: 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)
|
post-confinement (15 days, 3 months, 6 months)
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physical pain
기간: during confinement
|
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
|
during confinement
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physical pain
기간: 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)
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anger
기간: 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
기간: 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
기간: 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
기간: 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)
|
Use of psychotropic drugs
기간: 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
기간: 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)
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Tobacco consumption
기간: 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
기간: 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
기간: post-confinement (15 days, 3 months, 6 months)
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Number of patients declaring an increase of alcohol consumption
|
post-confinement (15 days, 3 months, 6 months)
|
alcohol consumption
기간: confinement
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Number of patients declaring an increase of alcohol consumption
|
confinement
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Illicit substances consumption
기간: confinement
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Number of patients declaring an increase of illicit substances consumption
|
confinement
|
Illicit substances consumption
기간: 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
기간: confinement
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Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
|
confinement
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orientation of life
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Emilie Olie, MD PhD, University Hospital, Montpellier
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .