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NCT04369300 Clinical Trial

Anxiety And Depression During COVID-19 IN INDIA

COVID-19 Clinical Trial

Official title:
Prevalence Of Anxiety And Depression During COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04369300
Other study ID # Covid-19/MHC/PSYCH/20-10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 24, 2020
Est. completion date February 24, 2021

Study information
Verified date July 2020
Source Max Healthcare Insititute Limited
Contact Sameer Malhotra
Phone 9891059770
Email Sameer.Malhotra@maxhealthcare.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

1. To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India

2. 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:

1. 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)

2. 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

3. 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.

4. Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by

Description:

Aim:

1. To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India

2. 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:

1. 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)

2. 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

3. 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.

4. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date February 24, 2021
Est. primary completion date November 24, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Registery Data Collection
Observational Data Collection

Locations
Country Name City State
India Max Super Speciality hospital New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence (magnitude) of anxiety of general adult population during COVID-19 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
Primary prevalence (magnitude) of depression and anxiety of general adult population during COVID 19 To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Patient Health Questionnaire (PHQ-9). 1 Year
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