Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000479909
Ethics application status
Approved
Date submitted
13/04/2020
Date registered
16/04/2020
Date last updated
9/02/2024
Date data sharing statement initially provided
16/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mental health and wellbeing on general population during the COVID-19 outbreak
Scientific title
Impact of Social Isolation on Mental Health during the COVID-19 Pandemic: a large international multi-centre cohort study
Secondary ID [1] 300968 0
None
Universal Trial Number (UTN)
Trial acronym
The IMSOMNIA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 316998 0
COVID19 317051 0
Social isolation 317052 0
Condition category
Condition code
Mental Health 315162 315162 0 0
Anxiety
Mental Health 315163 315163 0 0
Depression
Mental Health 315218 315218 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 315219 315219 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is designed as a cross-sectional, community-based observational study assessing the impact of social isolation on mental health (depression, anxiety, insomnia) during the COVID-19 pandemic.
The duration of the study is one month.
The duration of observation in each participant will be single 15 min assessment
Intervention code [1] 317290 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323456 0
the prevalence of depression which will be assessed by the 9-item Patient Health Questionnaire
Timepoint [1] 323456 0
Assessed at baseline
Primary outcome [2] 323474 0
the prevalence of anxiety, which will be assessed by the 7-item Generalized Anxiety Disorder scale
Timepoint [2] 323474 0
Assessed at baseline
Primary outcome [3] 323475 0
the prevalence of insomnia, which will be assessed by the 7-item Insomnia Severity Index.
Timepoint [3] 323475 0
Assessed at baseline
Secondary outcome [1] 382004 0
Severity of depression using the 9-item Patient Health Questionnaire
Timepoint [1] 382004 0
Assessed at baseline
Secondary outcome [2] 382021 0
Severity of anxiety using the 7-item Generalized Anxiety Disorder scale
Timepoint [2] 382021 0
Assessed at baseline
Secondary outcome [3] 382022 0
Severity of insomnia using the 7-item Insomnia Severity Index
Timepoint [3] 382022 0
Assessed at baseline

Eligibility
Key inclusion criteria
All adults who live in China, Australia, United States of America, Germany, Italy and Spain that are affected by the COVID-19 outbreak, have experienced social isolation due to COVID-19 pandemic. They are willing to participate in the study and able to complete the online survey.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Patient < 18 years of age at the time of the study

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Timing
Prospective
Statistical methods / analysis
The prevalence of depression, anxiety and insomnia related to social isolation will be calculated using the event rate. Multivariate logistic regression analysis will be performed to examine demographic factors predictive of the above mental disorders.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID 19 isolation and social distancing restrictions were constantly being reviewed and eased/lifted. It therefore became challenging to define social distancing and hence the relevance of the research questions.
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22485 0
China
State/province [1] 22485 0
Country [2] 22486 0
United States of America
State/province [2] 22486 0
Country [3] 22487 0
Italy
State/province [3] 22487 0
Country [4] 22488 0
Germany
State/province [4] 22488 0
Country [5] 22489 0
Spain
State/province [5] 22489 0
Country [6] 26141 0
Chile
State/province [6] 26141 0
Santiago

Funding & Sponsors
Funding source category [1] 305441 0
Other Collaborative groups
Name [1] 305441 0
The George Institute for Global Health
Country [1] 305441 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000
Country
Australia
Secondary sponsor category [1] 305838 0
None
Name [1] 305838 0
Address [1] 305838 0
Country [1] 305838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305736 0
Sydney Local Health District - Concord Repatriation General Hospital human research ethics committee
Ethics committee address [1] 305736 0
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 305736 0
Australia
Date submitted for ethics approval [1] 305736 0
17/04/2020
Approval date [1] 305736 0
18/12/2020
Ethics approval number [1] 305736 0

Summary
Brief summary
Since the first case reported in Wuhan city, China in December, 2019, COVID-19 has now become a pandemic issue and affected more than 1.5 million of people globally. On 23rd January, 2020, Chinese government implemented strict social isolation policy by locking down Wuhan city. Since then, COVID-19 outbreak has gradually been under control in China. However, a significant increase in incidence of COVID-19 occurred outside of China has made it a pandemic issue. More and more countries and cities adopted social isolation policy to ask their residents to stay at home for self-isolation and to maintain social distance in order to minimise disease transmission. On the other hand, this social isolation can also have psychological impacts such as anxiety and depression on the involved residents.

The IMSOMNIA study will provide initial unique insights into the impact of social isolation on mental health and to identify the group of people requiring intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101406 0
A/Prof Amanda Y Wang
Address 101406 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000
Country 101406 0
Australia
Phone 101406 0
+61 2 8052 4573
Fax 101406 0
Email 101406 0
awang@georgeinstitute.org.au
Contact person for public queries
Name 101407 0
Dr Qi Mei
Address 101407 0
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, People's Republic of China
postcode 430030
Country 101407 0
China
Phone 101407 0
+86 2783663405
Fax 101407 0
Email 101407 0
borismq@163.com
Contact person for scientific queries
Name 101408 0
A/Prof Amanda Y Wang
Address 101408 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000
Country 101408 0
Australia
Phone 101408 0
+61 2 8052 4573
Fax 101408 0
Email 101408 0
awang@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.