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

Depression Clinical Trial

— PsyConfPop  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374643
• Other study ID #: RECHMPL20_0197
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: Emilie Olie, MD PhD
• Phone: +33 4 67 33 85 81
• Email: e-olie[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• age> 18

Exclusion criteria:

• protective measure (curatorship, guardianship)

Related Conditions & MeSH terms

• COVID 19
• Depression

Intervention

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

Locations

Country	Name	City	State
France	University hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological pain	Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)	during confinement
Other	sleep	quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)	during confinement
Other	sleep	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)
Other	anxiety	anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)	during confinement
Other	anxiety	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)
Other	psychological pain	psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)	post-confinement (15 days, 3 months, 6 months)
Other	physical pain	psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)	during confinement
Other	physical pain	psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)	post-confinement (15 days, 3 months, 6 months)
Other	anger	staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)	during confinement
Other	anger	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)
Other	Stressful Event Impact	Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45); )	during confinement
Other	Stressful Event Impact	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)
Other	Use of psychotropic drugs	Number of patients declaring an increase of psychotropic drug use	during confinement
Other	Use of psychotropic drugs	Number of patients declaring an increase of psychotropic drug use	post-confinement (15 days, 3 months, 6 months)
Other	Tobacco consumption	Number of patients declaring an increase of tobacco consumption	during confinement
Other	Tobacco consumption	Number of patients declaring an increase of tobacco consumption	post-confinement (15 days, 3 months, 6 months)
Other	alcohol consumption	Number of patients declaring an increase of alcohol consumption	post-confinement (15 days, 3 months, 6 months)
Other	alcohol consumption	Number of patients declaring an increase of alcohol consumption	confinement
Other	Illicit substances consumption	Number of patients declaring an increase of illicit substances consumption	confinement
Other	Illicit substances consumption	Number of patients declaring an increase of illicit substances consumption	post-confinement (15 days, 3 months, 6 months)
Other	orientation of life	Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24	confinement
Other	orientation of life	Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24	post-confinement (15 days, 3 months, 6 months)
Primary	Depressive Symptomatology	depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)	during confinement
Secondary	Depressive Symptomatology	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