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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04374643
Collaborator
(none)
500
1
21
23.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Slef questionnaires fulfilment

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Confined patients

General population

Other: Slef questionnaires fulfilment
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months

Outcome Measures

Primary Outcome Measures

  1. Depressive Symptomatology [during confinement]

    depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)

Secondary Outcome Measures

  1. Depressive Symptomatology [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)

Other Outcome Measures

  1. Psychological pain [during confinement]

    Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

  2. sleep [during confinement]

    quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)

  3. sleep [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)

  4. anxiety [during confinement]

    anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)

  5. anxiety [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)

  6. psychological pain [post-confinement (15 days, 3 months, 6 months)]

    psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

  7. physical pain [during confinement]

    psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

  8. physical pain [post-confinement (15 days, 3 months, 6 months)]

    psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)

  9. anger [during confinement]

    staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)

  10. anger [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)

  11. Stressful Event Impact [during confinement]

    Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45) )

  12. Stressful Event Impact [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)

  13. Use of psychotropic drugs [during confinement]

    Number of patients declaring an increase of psychotropic drug use

  14. Use of psychotropic drugs [post-confinement (15 days, 3 months, 6 months)]

    Number of patients declaring an increase of psychotropic drug use

  15. Tobacco consumption [during confinement]

    Number of patients declaring an increase of tobacco consumption

  16. Tobacco consumption [post-confinement (15 days, 3 months, 6 months)]

    Number of patients declaring an increase of tobacco consumption

  17. alcohol consumption [post-confinement (15 days, 3 months, 6 months)]

    Number of patients declaring an increase of alcohol consumption

  18. alcohol consumption [confinement]

    Number of patients declaring an increase of alcohol consumption

  19. Illicit substances consumption [confinement]

    Number of patients declaring an increase of illicit substances consumption

  20. Illicit substances consumption [post-confinement (15 days, 3 months, 6 months)]

    Number of patients declaring an increase of illicit substances consumption

  21. orientation of life [confinement]

    Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24

  22. orientation of life [post-confinement (15 days, 3 months, 6 months)]

    Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
  • age> 18
Exclusion criteria:
  • protective measure (curatorship, guardianship)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Principal Investigator: Emilie Olie, MD PhD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04374643
Other Study ID Numbers:
  • RECHMPL20_0197
First Posted:
May 5, 2020
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2020