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CTRI Number  CTRI/2020/08/027118 [Registered on: 13/08/2020] Trial Registered Prospectively
Last Modified On: 12/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Personal Experience During COVID - 19 Pandemic 
Scientific Title of Study   Personal Experience During COVID - 19 Pandemic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Rohith Khanna 
Designation  Junior Resident at Dept of Psychiatry  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Dept of Psychiatry (Room No 23), Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur, Chennai TAMIL NADU 600116 India

Kancheepuram
TAMIL NADU
600116
India 
Phone  9677569253  
Fax    
Email  m2619004@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivian Kapil V 
Designation  Senior Resident at Dept of Psychiatry  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Dept of Psychiatry (Room No 23), Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur Chennai TAMIL NADU 600116 India

Kancheepuram
TAMIL NADU
600116
India 
Phone  9445431311  
Fax    
Email  viviankapil23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivian Kapil V 
Designation  Senior Resident at Dept of Psychiatry  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Dept of Psychiatry (Room No 23), Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur Chennai TAMIL NADU 600116 India

Kancheepuram
TAMIL NADU
600116
India 
Phone  9445431311  
Fax    
Email  viviankapil23@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research , No.1, Ramachandra Nagar, Porur, Chennai. Chennai TAMIL NADU 600116 India  
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [Not applicable ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR D Rohith Khanna  Sri Ramachandra Institute of Higher Education and Research   Dept of Psychiatry (Room No 23), Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur, Chennai. Chennai TAMIL NADU
Kancheepuram
TAMIL NADU 
9677569253

m2619004@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee (for Medical PG Students), SRIHER (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Participants aged 18 years and above.
2. Willing to participate in the study.
3. Ability to read, write and understand English language. 
 
ExclusionCriteria 
Details  1. Participants who are less than 18 years of age.
2. Participants who are unwilling to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DASS - 21 scores  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
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)   22/08/2020 
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="0"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION: 


Acute respiratory infectious diseases have emerged continuously over the past 20 years. In 2003, a severe acute respiratory syndrome (SARS) epidemic broke out in Guangdong Province, China, which had a lasting impact on public health in China and worldwide [1]. Since then, new epidemic outbreaks have continued to emerge, such as the H5N1 avian influenza A in 2004 [2], the H1N1 influenza A in 2009 [3], the Ebola virus in 2014 [4], and the Middle East respiratory syndrome in 2012 [5].

Human civilization probably is passing through the most critical juncture of this millennium while its existence is being challenged by the emergence of a novel severe acute respiratory syndrome coronavirus (SARS-Cov-2) encroaching newer territories all over the world expeditiously [6]. The outbreak of COVID-19 infection started in China in December 2019, and since then, it has spread to almost all the countries of the world by January–February 2020.[7] The World Health Organization (WHO) declared COVID-19 to be a pandemic on March 11, 2020, and as on July 17, 2020, there are 1,35,75,158 patients confirmed with COVID infection and 5,84,940 deaths have been reported to WHO (WHO website dated 17.07.2020 at 11:00 am Indian standard time) across 216 countries, areas, or territories.[7]

In India, cases of COVID-19 started to rise by the 2nd week of March 2020, and by July 17, 2020, India became the third highest country in the world with more than 10 lakhs COVID positive patients which includes 3,72,473 individuals with the active illness, 6,35,756 people cured/ discharged, and 25,000 deaths.(MOHFW, GOI)

The infections can be transmitted between individuals via close contacts and some of them could even develop fatal respiratory diseases like acute respiratory distress syndrome (ARDS) and acute respiratory failure ending up in intensive care.[8] The rapid transmission of this virus will increase the chances of psychological distress in different sub-populations and not limited to healthcare workers alone which could be due to quarantine measures, predominantly negative news portrayal, growing number of persons affected and suspected to have the infections and deaths all around the globe.[9] It is well known that quarantine/isolation for any cause and in the context of a pandemic (severe acute respiratory distress syndrome/SARS, 2003) had been reported to be associated with significant mental health problems ranging from anxiety, fear, depressive symptoms, sense of loneliness, sleep disturbances, anger, etc., in the immediate few days of isolation and later had symptoms of post traumatic stress disorder and depression even after 3–4 weeks of discharge.[10]  

As a public health emergency, COVID-19 has the characteristics of strong infectivity and rapid spread, as well as the limitations of the public’s cognition of COVID-19, the overwhelming news related to the pandemic, the cognitive bias of this emergency and other reasons, caused public anxiety and fear and other emotions.Even a mild illness with symptoms similar to COVID-19, such as the common cold, will enter a persistent state of anxiety.[11] A study surveyed in China analysed the psychological status of people at the beginning of the COVID-19 pandemic and the results showed that more than half of the respondents rated the psychological impact as moderate to severe, about 1/3 of the respondents reported moderate to severe anxiety, and 16.5% reported moderate to severe depressive symptoms[12].Therefore a country like India, facing a pandemic which is first of its kindthe psychological reaction of the public during this situation is very important and needs to be addressedAlso different coping strategies could contribute to different psychological outcomes including emotions and specific strategy could be efficient to certain symptom.[13,14] Therefore, the coping strategies towards this outbreak should also be evaluated .

With the incidence curve at its peak in India, at this critical point we aim to conduct this study to assess the psycho-behavioral changes in the Indian population after the COVID-19 outbreak in terms of psychological distress along with different behavioral practices to cope up with current situation. This study will be the first of its kind that aims to focus on the psychological impact, reactions to the condition and coping strategies employed during COVID-19 pandemic on a vast general population.


 AIMS AND OBJECTIVES:

1.    To assess the prevalence of  Depression, Anxiety and Stress levels among the Indian population during the current pandemic.

2.    To interpret the coping strategies employed by the general population towards the ongoing COVID-19 pandemic.

MATERIALS AND METHODS:

SITE OF STUDY: The study will be conducted among the general population throughout India.

STUDY DESIGN: Web based Cross sectional study

SAMPLE SIZE: Atleast 1000 responses.

SAMPLE:

The samples will be obtained from the general population throughout India using a web based cross sectional survey. For the purpose of the study, we will be using a snowball sampling strategy, to focus on recruiting the general public during the pandemic of COVID-19. The online survey will be disseminated through the investigating teams’ friends, colleagues and relatives and they will be encouraged to pass it on to others.  

SELECTION CRITERIA:

INCLUSION CRITERIA:

Participants satisfying all the following criteria are included in the study:

 

1.              Participants aged 18 years and above.

2.              Willing to participate in the study.

3.              Ability to read, write and understand English language.

 

EXCLUSION CRITERIA:

1.    Participants who are less than 18 years of age.

2.    Participants who are unwilling to participate in the study.

METHODOLOGY:

TOOLS AND INSTRUMENTS:

Demographics: A semi-structured questionnaire covering the demographic data, living conditions, medical history that includes mental health, knowledge and experience about COVID-19.

Instruments or materials: 

Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable /over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Each subscale comprises of seven statements regarding how the test subject was feeling over the last week and four responses ranging from 0‐ did not apply to me at all, 1‐ applied to me some of the time, 2‐ applied to me for a considerable amount of time to 3‐ applied to me very much/most of the time. The scoring system is of the Likert type and the total score for each subscale gives the severity of that very symptom which has a range from 0 to 21 for each subscale. Scores of  DASS-21 will need to be multiplied by 2 to calculate the final score. Cut-off scores are as follows : 

 

 

Depression

Anxiety

Stress

Normal

 0-9

0-7

0-14

Mild

10-13

8-9

15-18

Moderate

14-20

10-14

19-25

Severe

21-27

15-19

26-33

Extremely severe

28+

20+

34+

 

The original 42-item DASS of  Lovibond was modified into a shorter 21-item version.[12] Several studies are published on its reliability and validity worldwide, all showing the DASS-21 is a well-established instrument to measure symptoms of depression, anxiety and stress in both clinical and non-clinical samples of adults (Cronbach’s alpha scores of >0.7).[12,13,14,15] The DASS-21 has been shown to possess adequate construct validity and the reliabilities are high. [16]

 BRIEF COPE QUESTIONNAIRE

Coping strategies were assessed using the “Brief COPE scale”, which is a validated and abbreviated version of the COPE Inventory.[17] This 28-item scale did have acceptable internal consistency (α =0.75). It consists of 14 subscales/categories each having 2 items. These items ask what you’ve been doing to cope with each one. The scales are: ‘self-distraction’, ‘active coping’, ‘denial’, ‘substance use’, ‘use of emotional support’, ‘use of instrumental support’, ‘behavioural disengagement’, ‘venting’, ‘positive reframing’, ‘planning’, ‘humour’, ‘acceptance, ‘religion’ and ‘self-blame’. The answer choices depend upon how frequently each of these items are applied by the student, that is, ‘I haven’t been doing this at all’, ‘I’ve been doing this a little bit’, ‘I’ve been doing this a medium amount’, ‘I’ve been doing this a lot’ which are scored from 1 to 4, respectively. The scores on all the items were added separately to get the individual scores for each subscale as well as two major subscales. High scores on the scale indicate relatively greater use of a particular coping strategy. 

●     Procedure

       The study will be conducted among the general population from different parts of India affected with the COVID – 19 pandemic. Participants should be above 18 years. We will be using a web-based cross-sectional survey in order to prevent the spread of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) through droplets or contact and by which we are able to minimize face-to-face interaction. This web-based survey will be sent via electronic media (email, social media) by using an anonymous online questionnaire. By this way anyone using electronic media may come across this survey and answer the questionnaire by clicking the relevant link. The participants will remain anonymous wherein no identification information like name, email id, address will be collected and this will be assured with them. They will be given information about the nature of the study. There will also be given health information about COVID-19 and methods to Cope up with stress in a healthy way by Centre for Disease Control (CDC) at the end of the survey so that it could make people get the right information from an authentic source. The participants are also being provided with the contact details of the investigator so as to clarify their queries in this regard if any. Participants have the right to withdraw from the survey at any moment without providing any justification and that will not in any way hamper their further approach with the investigator regarding their queries.

 STATISTICAL ANALYSIS:

The data will be analyzed using SPSS software. Descriptive and analytical statistics will be used in relation to different variables and outcomes. Descriptive statistics- frequency distribution will be obtained for all discrete variables such as different age groups, educational qualification etc. Mean and standard deviation will be computed for all continuous variables. Descriptive analyses will be conducted to describe the demographic characteristics and other variables. Secondly, the prevalence of Depression, anxiety and stress will be assessed by the DASS-21 item scaleAnd individuals coping behaviour to the pandemic is assessed by Brief Cope questionnaire. Associations between variables and outcome (distress scores) will be done using Chi-square test (χ2). Independent t test, one-way ANOVA and Pearson correlation will be used to compare the differences between groups based on distress scores.

ETHICAL CONSIDERATIONS:

1.No invasive procedure will be carried out as a part of the current study

2.No additional benefits will be given to the participants

3.Confidentiality of the information obtained will be maintained

4.Participants have the right to withdraw from the study at any point of time 

 
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