Clinical trial NCT04369300: Anxiety And Depression During COVID-19 IN INDIA
Official title: Prevalence Of Anxiety And Depression During COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence (magnitude) of anxiety of general adult population during COVID-19
timeFrame: 1 YEAR
measure: prevalence (magnitude) of depression and anxiety of general adult population during COVID 19
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality hospital
state: Delhi
Study officials:
affiliation: max healthcare
name: Sameer Malhotra
role: PRINCIPAL_INVESTIGATOR
References: