An observational study in Depression and COVID 19, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by University Hospital, Montpellier · Observational
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
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 :
It is expected to highlight :
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.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 500 is above the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults who agree to participate by answering the questionnaires
Exclusion criteria:
General population
Other: Slef questionnaires fulfilment
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
Depressive Symptomatology
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -\> min : 0 max : 27)
Time frame: during confinement
Depressive Symptomatology
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -\> min : 0 max : 27)
Time frame: post-confinement : 15 days, 3 months, 6 months
Psychological pain
Psychological pain : likert scale (higher score, more psychological pain-\> min : 0 max : 10)
Time frame: during confinement
sleep
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -\> min : 0 max : 28)
Time frame: during confinement
sleep
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -\> min : 0 max : 28)
Time frame: post-confinement (15 days, 3 months, 6 months)
anxiety
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -\> min : 0 max : 21)
Time frame: during confinement
anxiety
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -\> min : 0 max : 21)
Time frame: post-confinement (15 days, 3 months, 6 months)
psychological pain
psychological pain : likert scale (higher score, more psychological pain-\> min : 0 max : 10)
Time frame: post-confinement (15 days, 3 months, 6 months)
physical pain
psychological pain : likert scale (higher score, more psychological pain-\> min : 0 max : 10)
Time frame: during confinement
physical pain
psychological pain : likert scale higher score, more psychological pain-\> min : 0 max : 10)
Time frame: post-confinement (15 days, 3 months, 6 months)
anger
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -\> min : 0 max : 50)
Time frame: during confinement
anger
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -\> min : 0 max : 50)
Time frame: post-confinement (15 days, 3 months, 6 months)
Stressful Event Impact
Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -\> min : 0 max : 45) )
Time frame: during confinement
Stressful Event Impact
Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -\> min : 0 max : 45)
Time frame: post-confinement (15 days, 3 months, 6 months)
Use of psychotropic drugs
Number of patients declaring an increase of psychotropic drug use
Time frame: during confinement
Use of psychotropic drugs
Number of patients declaring an increase of psychotropic drug use
Time frame: post-confinement (15 days, 3 months, 6 months)
Tobacco consumption
Number of patients declaring an increase of tobacco consumption
Time frame: during confinement
Tobacco consumption
Number of patients declaring an increase of tobacco consumption
Time frame: post-confinement (15 days, 3 months, 6 months)
alcohol consumption
Number of patients declaring an increase of alcohol consumption
Time frame: post-confinement (15 days, 3 months, 6 months)
alcohol consumption
Number of patients declaring an increase of alcohol consumption
Time frame: confinement
Illicit substances consumption
Number of patients declaring an increase of illicit substances consumption
Time frame: confinement
Illicit substances consumption
Number of patients declaring an increase of illicit substances consumption
Time frame: post-confinement (15 days, 3 months, 6 months)
orientation of life
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --\> min : 0 max : 24
Time frame: confinement
orientation of life
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --\> min : 0 max : 24
Time frame: post-confinement (15 days, 3 months, 6 months)
Plan to share: Undecided — NC
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University Hospital, Montpellier