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Anxiety And Depression During COVID-19 IN INDIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369300
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Max Healthcare Insititute Limited

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

Condition or disease Intervention/treatment
COVID-19 Behavioral: Registery Data Collection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Prevalence Of Anxiety And Depression During COVID-19
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : November 24, 2020
Estimated Study Completion Date : February 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Behavioral: Registery Data Collection
    Observational Data Collection


Primary Outcome Measures :
  1. 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)

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369300


Contacts
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Contact: Sameer Malhotra 9891059770 Sameer.Malhotra@maxhealthcare.com
Contact: Shreya Singhal 9810022980 Sameer.Malhotra@maxhealthcare.com

Locations
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India
Max Super Speciality hospital Recruiting
New Delhi, Delhi, India, 110017
Contact: Sameer Malhotra    9891059770    Sameer.Malhotra@maxhealthcare.com   
Contact: Shreya Singhal    9810022980      
Sponsors and Collaborators
Max Healthcare Insititute Limited
Investigators
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Principal Investigator: Sameer Malhotra max healthcare
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Responsible Party: Max Healthcare Insititute Limited
ClinicalTrials.gov Identifier: NCT04369300    
Other Study ID Numbers: Covid-19/MHC/PSYCH/20-10
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms