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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04343664
Other study ID # MH-Covid19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Dr Cipto Mangunkusumo General Hospital
Contact Tjhin Wiguna, PhD
Phone +628129005599
Email twiga00@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date December 31, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers
Gender All
Age group 4 Years and older
Eligibility Inclusion Criteria: - Willing to participate on this study by signing the informed consent Exclusion Criteria: - No

Study Design


Locations

Country Name City State
Indonesia dr. Cipto Mangunkusumo General Hospital Jakarta Pusat DKI Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Tjhin Wiguna Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression The depression symptoms assessed by Patient Health Queationnaire-9 Scale. The range is 0 -27, the highest score means the highest depresive up to 5 minutes
Primary 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 up to 5 minutes
Primary 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 up to 7 minutes
Primary 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 up to 5 minutes
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