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\begin{document}


\def\RunningAuthor{Shilpa Gaidhane et al.}
\firstPage{360}
\articleType{Original Article}
\receivedDate{21 May 2020}
\acceptedDate{23 Jun 2020}
\revisedDate{22 Jun 2020}
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\title{Depression, Anxiety and Stress among the general population in the time of COVID-19 lockdown: A cross-sectional study protocol\textbf{\space }}
\author{Shilpa~Gaidhane\textsuperscript{*}\textsuperscript{1},  
            Nazli~Khatib\textsuperscript{2},  
            Quazi~Syed~Zahiruddin\textsuperscript{3},  
            Abhay~Gaidhane\textsuperscript{4},  
            Shital~Telrandhe\textsuperscript{5}, 
            Parth~Godhiwal\textsuperscript{6}~\\[5pt]{\textsuperscript{1}Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe), Wardha- 442001, Maharastra, India}~\\{\textsuperscript{2}Division of Evidence Synthesis, School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha-442001, Maharashtra, India}~\\{\textsuperscript{3}Department of Global Health, School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha-442001, Maharashtra, India}~\\{\textsuperscript{4}Department of Community Medicine, School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha-442001, Maharashtra, India}~\\{\textsuperscript{5}Division of Data Management, Stepping stones project, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha-442001, Maharashtra, India}~\\{\textsuperscript{6}Department of Medicine, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha-442001, Maharashtra, India}}

\begin{abstract}
The incidence of Depression, Anxiety and stress among the general population is steadily increasing due to outbreak of COVID-19 across the globe. Beyond the risks of COVID-19, concerns have been expressed to have mental effect on the general population due to COVID-19 lock down. The emotional impact is more among individuals with pre-existing medical diseases like hypertension, Coronary Artery Disease, Diabetes (DM) and psychiatric illness. The lockdown results in health anxiety, this can manifest as maladaptive behaviours (repeated medical consultations, avoiding health care even if genuinely ill, hoarding particular items); at a broader societal level, it can lead to mistrust of public authorities and scapegoating of particular populations or groups. There are very few data from India studying mental impact of lockdown due to COVID 19 among general population. In our study, we will assess DAS among rural population who are accompanying the Non-COVID 19 patients at a tertiary care rural hospital of central India in the era of lock down.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}COVID 19 pandemic,\newline Depression,\newline Anxiety and Stress,\newline General population
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Shilpa~Gaidhane~\\ Phone:\ +919673288822~\\  Email:\ drshilpagaidhane@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
Depression is a mental state, indicated by disturbed sleep or appetite, feeling sadness, feelings of guilt or low self-worth, feelings of tiredness, loss of interest or pleasure, and poor concentration. It may be episodic due to life-altering tragedy, or it may be a chronic condition. It impairs a person's ability to function appropriately with day to day activities of everyday life \unskip~\citep{822377:19687980}. Anxiety is defined as the feeling of worry, nervousness or unease about something with an uncertain outcome''; where-as ``stress is the state of mental or emotional strain or tension resulting from adverse or demanding consequences'' \unskip~\citep{822377:19687972}. The global burden of disease study, in India, nearly 45 million people are leaving with depressive disorders, and 44 million are affected by anxiety disorders \unskip~\citep{822377:19687980}. Moreover, the prevalence of DAS is steadily rising from 1990 to 2017.

At present entire human race is under the threat of COVID-19, and cases are reported in all continents across the globe and resulted in pandemic \unskip~\citep{822377:19687974}. It was first identified in Wuhan, China spreading to Europe and the United States of America. This calamity has also struck India gravely. As per WHO, on 11\ensuremath{^{th}} June 2020 more than two lacs population of India are infected with COVID 19 out of which 7745 people have succumbed to the disease \unskip~\citep{822377:19687971}. While there is increasing global responsiveness towards coronavirus pandemic in the form of lockdown, quarantine, isolation to prevent the transmission of COVID 19, an alarm is being raised for emotional and psychological effect in terms of Depression, Anxiety and Stress among non-infected general population during this unique, severe conditions of lockdown \unskip~\citep{822377:19687977,822377:19687981}. As general public does not have access to primary medical care because of mass lockdown, restrictions and absences of public transport, these factors may increase in psychological problems, including anxiety, depression, and stress (DAS) among the general population \unskip~\citep{822377:19687977,822377:19687982}. Furthermore "unpredictability, uncertainty, the seriousness of the disease, misinformation and social isolation may contribute to stress and mental morbidity among the general population \unskip~\citep{822377:19687970}. \unskip~\cite{822377:19687973} reinforced in their study result that economic impact of COVID-19 affects general psychological well-being, as well as the possible high levels of fear and panic behaviour, such as hoarding and stockpiling of resources, in the general population.  

These emotional problems may be more pronounced in persons having non-communicable chronic comorbid diseases like Hypertension(HTN), Diabetes Mellitus (DM), Coronary artery diseases (CAD), and chronic pulmonary diseases (COPD). They also are at increased risk of mortality due to COVID 19 infection. Because of additional mental stress of COVID-19 pandemic, many physicians, researchers and psychiatrists have contemplated a rising trend of risk of DAS or relapse of previous mental health diseases \unskip~\citep{822377:19687978}.

Moreover, Ho et al. in their report discussed the role of improved screening for mental disorders, improving links between community and hospital services, and providing accurate information to the general public to minimise maladaptive responses such as "panic" and paranoia regarding the disease and its transmission \unskip~\citep{822377:19687976}. Lima et al. highlighted the role of anxiety as the dominant emotional response to COVID 19 outbreak, and lockdown \unskip~\citep{822377:19687977}. There is also a need for adequate training of healthcare personnel to provide mental health care. 

There is a lack of data in India, documenting the mental health of the general population in the era of lockdown due to COVID-19 pandemic and lockdown. Hence we proposed this study intending to find out the prevalence of Depression, Anxiety, Stress (DAS) among the rural population who are accompanying the Non-COVID 19 patients at a tertiary care rural hospital in central India. We also want to determine the risk factors associated with DAS for early identification to prevent or minimise the psychological impact of COVID 19 lockdown. 
    
\section{Materials and Methods\textbf{\space }}
\textbf{Approval of ethics committee}

The study will be started after seeking ethical approval from the Datta Meghe Institute of Medical Sciences Institutional Ethical Committee.\textbf{\space }


\begin{table*}[!htbp]
\caption{\boldmath {Classification of severity of DAS} }
\label{tw-e28d64c53596}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2518\linewidth-2\tabcolsep}p{\dimexpr.2482\linewidth-2\tabcolsep}p{\dimexpr.25\linewidth-2\tabcolsep}p{\dimexpr.25\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor} & Depression  & Anxiety  & Stress\\
\tblmidrule 
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+\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
\textbf{Study design}

This will be a single-centre cross-sectional study using validated DASS-21 English and Marathi involving self-administered questionnaire.

\textbf{Study setting}

This study will be conducted among the participants attending medicine OPD in Acharya Vinoba Bhave Rural Hospital (AVBRH), DMIMSU, Sawangi, Wardha, Maharashtra. AVBRH hospital caters to the rural population of Wardha district of Maharashtra. During Lockdown district, borders are sealed, and public transport is not available. Private vehicles or ambulance is allowed to cross the district border after availing permission from collector office. After procuring the permissions, patients of surrounding districts like Yeotmal, Chandrapur, Gadchiroli, Bhandara, Nagpur and Amaravati of Maharashtra obtain medical opinion and services from AVBRH. 

\textbf{Study population}

\textbf{Inclusion criteria}


  
  \begin{enumerate}
  \item \relax Asymptomatic patient's relatives accompanying the Non-COVID-19 patient attending the medicine OPD will be included in the study. The non-COVID-19 patient is a patient who does not have symptoms and sign of COVID-19 (as per the WHO case definition of COVID-19) (9). 
  \item \relax Asymptomatic adult (more than 18 years) participants with either gender. 
  \item \relax The participant with comorbid conditions like Hypertension (HTN), Diabetes Mellitus (DM), Coronary artery diseases (CAD), and chronic pulmonary diseases (COPD) will be included.
  \end{enumerate}
  \textbf{Exclusion criteria}


  
  \begin{enumerate}
  \item \relax Participants with any symptoms of the respiratory, cardiac or abdominal system. 
  \item \relax Participants with any mental illness, any drugs affecting mood, affect and behaviour, cognitive impairment, malignancy, or chronic kidney diseases. 
  \end{enumerate}
  \textbf{Sample size}

The Sample size of our study will be 246 anticipated population proportions of DAS as 20\% with 95\% confidence interval and absolute precision of 5 \% points \unskip~\citep{822377:19687979}.\textbf{\space }

\textbf{Data collection tools and measurements}

The persons who can read, understand and write English will be given an English version of the DASS-21 questionnaire \unskip~\citep{822377:19687975}. As a most common language spoken in our rural population is Marathi, hence validated DASS 21 questionnaire translated in Marathi will be used for detection of DAS. The questionnaire will be self-administered.  The questionnaire contains four sections (i) socio-demographic information (ii) knowledge about COVID 19 (iii) Presence of comorbid condition and (iv) 21 questions for detection of DAS, will be given to the patient's relatives when attending medicine OPD. 

The socio-demographic profile like age, gender, professions, marital status, education level, occupations and household income will be documented. Factors which may influence the incidence, prevalence and severity of DAS such as smoking status, presence of co-morbidities, like the history of diabetes mellitus, hypertension, CAD, chronic pulmonary diseases and psychiatric illness will also be noted.  

The identification of DAS will be made using validated DASS-21 questionnaire. It consists of three self-reported scales, which are devised to measure the negative mental states of DAS. The DASS-21 census has 21 questions, which assess the symptoms of depression, anxiety and stress, respectively \unskip~\citep{822377:19687975}. The patients will be asked to rate their experience on each symptom on a 4-point severity scale ranging from '0' (does not apply to me), to '3' (applies to me most of the time). The DASS-21 questionnaire will be translated into the Marathi language, which has been validated for its use. 

Scores of each scale will be added up and multiplied by two and then classified as usual, mild, moderate, severe and extremely severe as per the total score, according to DASS manual tool generated by Sydney: Psychology Foundation in 1995. 

\textbf{Data collection procedure}

All the study participants will be screened for symptoms for COVID 19 at the screening OPD. The patient and their relative are asked to wash hands at screening OPD. The temperature of the patient and patient's relative is taken by Health care workers by Touchless thermometer. Once the temperature is average, patients can be allowed to attend Medicine OPD. If the temperature is found to be raised, they are admitted at the suspect ward and the isolation of their relatives. In Medicine OPD, Patients relative will be screened for study eligibility criteria by trained Investigators.  

The eligible study participants giving informed written consent will be asked to fill a questionnaire to their best knowledge and feelings. They will be provided with patient socio-demographic information sheet, the pilot-tested English and Marathi version of the DASS-21 self-administered questionnaire. The questionnaire will be filled up while awaiting their turn to be seen by the doctor. During the consultation with the doctor, the survey will be checked for its completion. 

Safety measures like hand washing before entering Medicine OPD, use of mask and physical distancing in the waiting area, using alcohol rub before and after filling the Pro-forma, will be maintained. After filling the questionnaire, all the forms collected at the end of a single day will be kept in a sealed box. The box will be opened on the fourth day, and data will be explored.

\textbf{Data analysis}

Data will be checked for inconsistency and completeness. DASS 21 is a collection of seven self-answered questions for detecting Depression, Anxiety and Stress. Scores on each scale will be added up and multiplied by two and then classified as usual, mild, moderate, severe and extremely severe as per the total score, according to the DASS manual tool generated by Sydney: Psychology Foundation in 1995 \unskip~\citep{822377:19687975} as shown in Table~\ref{tw-e28d64c53596}. 

All analyses will be pre-specified, and codes and will be ready for the review. Analyses will be done with Stata MP (version 14). All continuous variables will be expressed as mean and standard deviation. All Categorical variables will be expressed as frequency and percentage. The core outcome variables will be depression, anxiety, and stress.
    
\section{Discussion}
We will be able to find out the prevalence of Depression, Anxiety, Stress (DAS) among the rural population who are accompanying the Non-COVID-19 patients at a tertiary care rural hospital of central India during lockdown. We will also be able to determine the risk factors associated with DAS. We will discuss our findings of this study and compare it with the other relevant reviews. 

This study will help clinicians in early identification of DAS, and its risk factors and to prevent or minimise the psychological impact of COVID 19 lockdown. It will also help the policymakers to frame policies keeping in view the mental health status of the general population. We will conclude the study based on the result observed in the study.
    
\section{Conclusion}
The COVID-19 pandemic and lockdown have led to varying mental health problems response in the general population, among healthcare workers, and in vulnerable populations. There is a need for further research, to assess the effect of covid 19 pandemics and resulting lockdown in India, particularly in the rural community where mental health infrastructure is less developed, and the impact is likely to be more severe.
\section*{Acknowledgement}Nil.

\textbf{Funding Support}

Nil.

\textbf{Conflict of Interest}

Nil.
    

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