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Trial details
Trial details
The effect of confinement on the mental health of individuals during the COVID-19 pandemic: an online survey
Current status:
Approved
|
Date registered:
16/04/2020
|
Date last updated:
16/04/2020
Trial version(s)
Current: 11/04/2020
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Main Information
Primary registry identifying number
LBCTR2020043459
Protocol number
HDF 1632
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
11/04/2020
Primary sponsor
Hotel Dieu de France hospital
Primary sponsor: Country of origin
Lebanon
Public title
The effect of confinement on the mental health of individuals during the COVID-19 pandemic: an online survey
Acronym
Scientific title
The effect of confinement on the mental health of individuals during the COVID-19 pandemic: an online survey
Acronym
Brief summary of the study: English
This an online survey aiming at screening most common mental disorders occurrence (depression, anxiety, eating disorders and substance use disorders) in the general population of Lebanese individuals under confinement. The study will use 3 screening questionnaires: DASS-21, SCOFF and CAGE-AID in Arabic, English and French. Three groups divided among those who have a minimal, moderate or severe impact of the confinement on their lifestyle will be created and their scores on screening questionnaires will be compared.
Brief summary of the study: Arabic
يهدف هذا الاستطلاع عبر الإنترنت إلى فحص معظم الاضطرابات النفسية الشائعة (الاكتئاب والقلق واضطرابات الأكل واضطرابات تعاطي المخدرات) في عموم السكان اللبنانيين تحت الحبس. ستستخدم الدراسة 3 استبيانات للفحص: DASS-21 و SCOFF و CAGE-AID باللغات العربية والإنجليزية والفرنسية. سيتم إنشاء ثلاث مجموعات مقسمة بين أولئك الذين لديهم تأثير الحد الأدنى أو المعتدل أو الشديد للحبس على نمط حياتهم ومقارنة درجاتهم في استبيانات الفحص.
Health conditions/problem studied: Specify
Mental Disorders
Interventions: Specify
Online survey dividing participants to three groups according to the level of influence of confinement on their lifestyle
Key inclusion and exclusion criteria: Inclusion criteria
Age > 18 years Living in Lebanon Speaking English Arabic or French
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
85
Key inclusion and exclusion criteria: Exclusion criteria
Refusal to participate
Type of Study
Type
Observational
Study model
Cohort
Study model: Explain model
Cross-sectional online survey comparing 3 groups
Time perspective
Other
Time perspective: Specify perspective
N/A
Time perspective: Explain time perspective
Transversal assessing current month's psychological well-being
Target follow-up duration
1
Target follow-up duration: Unit
N/A
Number of groups/cohorts
3
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
500
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
14/04/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
18/05/2020
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
N/A
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rami
Bou Khalil
rami.boukhalil@usj.edu.lb
Lebanon
01615300
rami.boukhalil@usj.edu.lb
Saint Joseph University
Scientific
Rami
Bou Khalil
rami.boukhalil@usj.edu.lb
Lebanon
01615300
rami.boukhalil@usj.edu.lb
Saint Joseph University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France
Rami Bou Khalil; Ramez Dagher; Ghassan Sleilaty; Sami Richa
Psychiatry and cardiothoracic surgery
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
09/04/2020
Sami Richa
sami.richa@usj.edu.lb
01615300
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Depression
Depressive episode (F32)
Depression
Anxiety
Anxiety disorder, unspecified (F41.9)
Anxiety
Interventions
Intervention
Description
Keyword
N/A (online survey)
Online survey assessing mental health during the last month
Mental Health; Online survey; Confinement
Primary Outcomes
Name
Time points
Measure
Mental disorders (Depression; anxiety; eating disorders; substance use disorders)
one month
DASS-21; SCOFF; CAGE-AID
Key Secondary Outcomes
Name
Time points
Measure
N/A
N/A
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
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