Mental StressNewNCT04343664
Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia
An observational study of Mental Stress and Mental Health Wellness 1, run by Tjhin Wiguna at 1 site in Indonesia.
Trial summary
The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Mental Stress, Mental Health Wellness 1, Depression
- How many people
- 10,000 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2021to 31 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Child, Adult, Older adult
Study population: All children, parents and community members
Who may be able to join
- Willing to participate on this study by signing the informed consent
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community.
Read the detailed description
The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community. The aims of this study are trying to collect and identify the most important aspect of mental health that affected by the Covid-19 pandemic in Indonesia, and using this data we are trying to propose the exact mental health promotion and prevention program for the community. The study design is cross sectional. We develop the questionnaire that suitable for our study, consists of demographic data, life experience data. In addition, for assessing mental health problems, the study uses PHQ-9, SRQ-20, GAD-7, SDQ for children 4 - 10 years old and 11 - 17 years old. The study is done by online survey. The data analysis is done by SPSS for mac version 21.
- Conditions
- Mental Stress, Mental Health Wellness 1, Depression, Anxiety, Behavior Problem, Emotional Problem
- Keywords
- Mental health, Covid-19, Pandemic, Indonesia
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders, Mental Disorders, Psychological Well-Being, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The depression symptoms assessed by Patient Health Queationnaire-9 Scale. The range is 0 -27, the highest score means the highest depresive
Measured: up to 5 minutes
Anxiety symptoms
The anxiety symptoms assessed by Generalized Anxiety Disorder -7 Scale. It is consists of 7 item with ranged score 0 -21. The highest score means the highest anxiety
Measured: up to 5 minutes
Stress related problems
The stress related problems assessed by Self Reporting Questionnaire-20 Scale. The range is 0 -20, the highest score means the highest mental health problems
Measured: up to 7 minutes
Behavior and emotional problem among children and adolescents
Behavior and emotional problem among children and adolescents assessed by Strength and Difficulties Questionnaire. SDQ consists of 25 statements, the score is ranged from 0 - 60. The highest score means the highest problems
Measured: up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tjhin Wiguna
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Sponsor-investigator, Tjhin Wiguna, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Tjhin Wiguna, PhD, Principal investigator, Dr Cipto Mangunkusumo General HospitalTjhin Wiguna, PhD, Principal investigator, Fakultas Kedokteran Univeristas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343664
- Sponsor's protocol ID
- MH-Covid19
- Acronym
- New
- Status last verified
- Feb 2021
- First submitted
- 9 Apr 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia
- ClinicalTrials.gov ID
- NCT04343664
- Acronym / sponsor ID
- New / MH-Covid19
- Conditions
- Mental Stress, Mental Health Wellness 1, Depression, Anxiety, Behavior Problem, Emotional Problem
- Keywords
- Mental health, Covid-19, Pandemic, Indonesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Tjhin WigunaUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community.
Detailed description
The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community. The aims of this study are trying to collect and identify the most important aspect of mental health that affected by the Covid-19 pandemic in Indonesia, and using this data we are trying to propose the exact mental health promotion and prevention program for the community. The study design is cross sectional. We develop the questionnaire that suitable for our study, consists of demographic data, life experience data. In addition, for assessing mental health problems, the study uses PHQ-9, SRQ-20, GAD-7, SDQ for children 4 - 10 years old and 11 - 17 years old. The study is done by online survey. The data analysis is done by SPSS for mac version 21.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All children, parents and community members
Key inclusion criteria (1 listed)
- Willing to participate on this study by signing the informed consent
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression
Time frame: up to 5 minutes
The depression symptoms assessed by Patient Health Queationnaire-9 Scale. The range is 0 -27, the highest score means the highest depresive
Anxiety symptoms
Time frame: up to 5 minutes
The anxiety symptoms assessed by Generalized Anxiety Disorder -7 Scale. It is consists of 7 item with ranged score 0 -21. The highest score means the highest anxiety
Stress related problems
Time frame: up to 7 minutes
The stress related problems assessed by Self Reporting Questionnaire-20 Scale. The range is 0 -20, the highest score means the highest mental health problems
Behavior and emotional problem among children and adolescents
Time frame: up to 5 minutes
Behavior and emotional problem among children and adolescents assessed by Strength and Difficulties Questionnaire. SDQ consists of 25 statements, the score is ranged from 0 - 60. The highest score means the highest problems
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No. Undecided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjhin Wiguna, PhD principal investigator
Dr Cipto Mangunkusumo General Hospital
Tjhin Wiguna, PhD principal investigator
Fakultas Kedokteran Univeristas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Stress and Mental Health Wellness 1, run by Tjhin Wiguna at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tjhin Wiguna, PhD (+628129005599, twiga00@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: up to 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.