- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369300
Anxiety And Depression During COVID-19 IN INDIA
Prevalence Of Anxiety And Depression During COVID-19
- To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India
- To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India
Hypothesis:
There is likelihood of significant symptoms of depression and anxiety among general population in India during the current COVID-19 outbreak.
Procedure:
The participants would be selected with their informed consent. The objective of the study would be clearly written on Page 1 of the survey. The test would be administered electronically by all the participants individually only when consented to the study. The data collected will be kept strictly confidential and the identity of the participants will not be disclosed at any point of the research
Measures:
- Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level ofEducation, current living arrangement (e.g. staying alone or with family) and Occupation. It further includesregular employment status and current employment status(e.g, Work from home, temporary leave, termination etc)
- History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness
- COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includesinformation on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19.
- Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by
Study Overview
Detailed Description
Aim:
- To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India
- To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India
Hypothesis:
There is likelihood of significant symptoms of depression and anxiety among general population in India during the current COVID-19 outbreak.
Procedure:
The participants would be selected with their informed consent. The objective of the study would be clearly written on Page 1 of the survey. The test would be administered electronically by all the participants individually only when consented to the study. The data collected will be kept strictly confidential and the identity of the participants will not be disclosed at any point of the research
Measures:
- Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level of Education, current living arrangement (e.g. staying alone or with family) and Occupation. It further includes regular employment status and current employment status(e.g, Work from home, temporary leave, termination etc)
- History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness
- COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includes information on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19.
- Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9)
Primary outcome To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Generalized Anxiety Disorder Scale (GAD-7) and Patient Health Questionnaire (PHQ-9). Rise in Anxiety and Depression will be noted.
Through the analysis of the results, help device psychological intervention/mental health programs geared towards general and specific symptoms and management of emotional needs can be provided to the general population during and post-crisis.
Secondary Outcome Through the analysis of the results, it will help device psychological intervention/mental health programs geared towards general and specific symptoms and management of emotional needs can be provided to the general population during and post-crisis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110017
- Recruiting
- Max Super Speciality Hospital
-
Contact:
- Sameer Malhotra
- Phone Number: 9891059770
- Email: Sameer.Malhotra@maxhealthcare.com
-
Contact:
- Shreya Singhal
- Phone Number: 9810022980
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants of the age of 18 years and above
Participants residing in India
Participants with minimum 10 years of education with basic knowledge of English
Description
Inclusion Criteria:
- Participants of the age of 18 years and above
- Participants residing in India
- Participants with minimum 10 years of education with basic knowledge of English
Exclusion Criteria:
- Participants under the age of 18 years
- Participants residing outside of India
- Participants with previous history of any major psychiatric illness, psychiatric hospitalization or currently on any psychiatric medication.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence (magnitude) of anxiety of general adult population during COVID-19
Time Frame: 1 YEAR
|
To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Generalized Anxiety Disorder Scale (GAD-7)
|
1 YEAR
|
|
prevalence (magnitude) of depression and anxiety of general adult population during COVID 19
Time Frame: 1 Year
|
To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Patient Health Questionnaire (PHQ-9).
|
1 Year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sameer Malhotra, max healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Covid-19/MHC/PSYCH/20-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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