Mental Health Assessment Among Community Member During th... | NCT04343664

Studies
Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia

NCT04343664

Sponsor

Tjhin Wiguna

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Mental Stress
Mental Health Wellness 1
Depression
Anxiety
Behavior Problem
Emotional Problem

Interventions

Not provided

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Apr 9, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2021

Last Update Posted Date

Feb 9, 2021Actual

Name	Class
Fakultas Kedokteran Universitas Indonesia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing to participate on this study by signing the informed consent

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All children, parents and community members

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tjhin Wiguna, PhD	Contact	+628129005599		twiga00@yahoo.com
Belinda J Murtani, dr.	Contact	+62817198097		belindamurtani@yahoo.com

Overall Officials

Name	Affiliation	Role
Tjhin Wiguna, PhD	Dr Cipto Mangunkusumo General Hospital	Principal Investigator
Tjhin Wiguna, PhD	Fakultas Kedokteran Univeristas Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
dr. Cipto Mangunkusumo General Hospital		Jakarta Pusat	DKI Jakarta	10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Undecided yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological
D003863	Depression
D001008	Anxiety Disorders
D001523	Mental Disorders
D000092862	Psychological Well-Being
D000086382	COVID-19

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010549	Personal Satisfaction
D011024	Pneumonia, Viral

Browse Leaves

Not provided

Browse Branches

Not provided