Psychosocial and Behavioral Effects of COVID-19 Pandemic in the Indian Population: A Cross-Sectional Study Protocol.

Joshi, Megha; Shah, Aangi; Trivedi, Bhavi; Patel, Viral; Trivedi, Jaahnavee; Parghi, Devam; Thakkar, Manini; Barot, Kanan; Jadawala, Vivek

BACKGROUND During the year 2020, the COVID - 19 pandemic spread from China to the rest of the world, leading the world to a widespread mandated quarantine or suggested social isolation. The impending uncertainty due to the pandemic must have led to a variety of widespread mental health maladies. There has been documentation in the literature about a lot of these in small populations of the world but limited studies and generated evidence from it has been conducted in India. The main objective of our study was to investigate the mental health effects of COVID-19 on the general population in India - both quantitatively and qualitatively. These results would help contribute to the knowledge gap recognized in the literature, given the unprecedented and novel nature of the pandemic. OBJECTIVE Aim 1.1: We aim to qualitatively analyze the psychosocial and behavioral effects among the target population via online survey forms and present them in an easily readable way. Aim 1.1 will be accomplished by collecting the data via the use of the 'google forms' survey and using the same software to present data in the form of different kinds of charts such as bar, pie, etc. These will be included in the 'tables and charts' section of the research article. Aim 1.2: We aim to quantitatively analyze and determine the extent of these associations and their statistical significance. Aim 1.2 will be accomplished by using STATA software to analyze the demographic variables across with the data on the psychosocial and behavioral effects by using methods such as logistic regression, chi-square analysis, etc. depending on the kind of variables being analyzed. The results of this analysis will also be included in the 'analysis' section of the research article. METHODS We designed and validated our own questionnaire and utilized the method of circulating it via WhatsApp. WhatsApp is a social media app very popularly used in India, and hence turned out to be an effective medium to gather pilot data. We analyzed the pilot data and used it to validate the questionnaire with the expertise of our mentor, Dr. Nilima Shah MD psychiatry. RESULTS The study protocol was approved in September 2020 by the IRB at Vadilal Sarabhai General Hospital, Ahmedabad, Gujarat, India. We gathered pilot data of 545 subjects and used the results to determine the changes needed to the questionnaire, while simultaneously validating it. CONCLUSIONS The following preliminary assumptions can be made about the study from the pilot data: the majority of the survey respondents were male (53%: 289/545), most of them were educated and employed as healthcare workers (36.5%: 199/545). The majority of the responders were self-employed (33.9%: 185), single (54.5%: 297/545), and stayed with their family for the lockdown, which helped psychologically. Findings specific to mental health have been elaborated in the manuscript below. It is evident from the data collected in the literature previously, that the pandemic had significantly detrimental effects on the mental health of a vast proportion of the Indian population. CLINICALTRIAL INTERNATIONAL REGISTERED REPORT DERR1-10.2196/29896.