| CTRI Number |
CTRI/2020/04/024784 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ANXIETY AND DEPRESSION DURING COVID-19 IN INDIA |
|
Scientific Title of Study
|
PREVALENCE OF SYMPTOMS OF ANXIETY AND DEPRESSION DURING COVID-19 IN INDIA: A WEB-BASED CROSS-SECTIONAL STUDY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer Malhotra |
| Designation |
Senior Consultant Psychiatrist and Director, Department of Mental Health and Behavioural Sciences |
| Affiliation |
Max Super Speciality Hospital |
| Address |
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9560043590 |
| Fax |
|
| Email |
sameer.malhotra@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreya Singhal |
| Designation |
Psychologist |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9810022980 |
| Fax |
|
| Email |
singhal.shreya21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Singhal |
| Designation |
Psychologist |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9810022980 |
| Fax |
|
| Email |
singhal.shreya21@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF-SPONSORED. NO CONFLICT OF INTEREST. |
|
|
Primary Sponsor
|
| Name |
Dr Sameer Malhotra SELF SPONSORED NO CONFLICT OF INTEREST |
| Address |
NO EXTERNAL SPONSOR AND NO CONFLICT OF INTEREST
MAX SUPER SPECIALITY HOSPITAL
1 PRESS ENCLAVE, SAKET, NEW DELHI 110017 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sameer Malhotra |
Max Super Speciality Hospital |
1 Press Enclave, Saket
New Delhi India 110017
South
DELHI |
9810022980
sameer.malhotra@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Specialiity Hospital, Saket, New Delhi, India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
B972||Coronavirus as the cause of diseases classified elsewhere |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Participants under the age of 18 years
Participants residing outside of IndiaÂ
Participants with previous history of any major psychiatric illness, psychiatric hospitalization or currently on any psychiatric medication.Â
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
1 month during the period of COVID-19 pandemic.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
1 month during the period of COVID-19 pandemic. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 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) |