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CTRI Number  CTRI/2022/01/039678 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 03/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Estimation of prevalence of Depression, Anxiety and Stress among Tuberculosis patients  
Scientific Title of Study   A cross-sectional study of prevalence of depression, anxiety and stress among tuberculosis patients in an Udupi district, Karnataka, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalyani R Nadgir 
Designation  Postgraduate Student  
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy Prasanna School of Public Health Room No 61 Manipal Academy of Higher Education Manipal Madhav Nagar, Eshwar Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9449581996  
Fax    
Email  kalyani.nadgir@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr P Arathi Rao 
Designation  Associate Professor, Coordinator-MPH Programme 
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy Prasanna School of Public Health Room No 60 Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008418848  
Fax    
Email  arathi.anil@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kalyani R Nadgir 
Designation  Postgraduate Student  
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy Prasanna School of Public Health Room No 61 Manipal Academy of Higher Education Manipal Madhav Nagar, Eshwar Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9449581996  
Fax    
Email  kalyani.nadgir@learner.manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public Health Department of Health Policy Manipal Academy of Higher Education Manipal, Karnataka, India.  
 
Primary Sponsor  
Name  Dr Kalyani R Nadgir 
Address  Postgraduate Student Department of Health Policy Prasanna School of Public Health Room No 61 Manipal Academy of Higher Education Manipal 
Type of Sponsor  Other [Self-Funded] 
 
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 Chidananda Sanju SV  Tuberculosis Centre - Udupi District  District TB Elimination Office Room No 4 Behind District Health Office Ajjarkadu, Udupi, 576101
Udupi
KARNATAKA 		 9448106365

sanjuchida@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A15-A19||Tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients registered at "NIKSHAY", Udupi Tuberculosis Unit above 18 years of age and availing services at Government facilities 
 
ExclusionCriteria 
Details  People living with HIV (PLHIV) with Tuberculosis as a comorbidity
Patients with diagnosis of or who were undergoing treatment for psychiatric history prior to the onset of Tuberculosis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence and factors contributing to Depression, Anxiety and Stress among Tuberculosis Patients   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Identified patients with Depression, Anxiety and Stress patients will be referred to concerned medical Officer for further management.
The findings of the study will be used to inform the TB care continuum in the Udupi district for necessary recommendations to the concerned authorities.  		 18 weeks 
 
Target Sample Size   Total Sample Size="245"
Sample Size from India="245" 
Final Enrollment numbers achieved (Total)= "245"
Final Enrollment numbers achieved (India)="245" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 28/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Tuberculosis has been a severe public health problem for thousands of years, impacting the poorest, most vulnerable, and socially excluded people. Worldwide, Tuberculosis (TB) is the 13th leading cause of death and the second leading infectious killer after COVID-19 [1]. According to WHO, there were 10 million new TB cases and 1.5 million deaths due to TB in 2020, accounting for 86 percent of new TB cases from the 30 high TB burden countries, with India leading the count [1]. According to TB India 2021 report, 1.80 million cases were reported across the country, with 65,785 incidence in Karnataka[2]. TB and mental health have a complex association[4]. According to WHO, “Mental health is a state of complete well-being in which an individual realizes his or her own capabilities, can cope with normal stress of life, can work productively and is able to make contribution to his or her community”[5]. Fatigue caused by the condition, as well as the resulting loss of work and wages, causes psychosocial stress and worsens mental health[4]. The stigma and discrimination typically associated with TB worsens the illness’s environment. Thus, the declaration there is no health without mental health[4].This study is therefore an attempt to study the prevalence of depression, anxiety and stress burden among TB patients in Udupi; where it will serve as a preliminary to further larger scale studies in our population providing a much needed evidence base. The findings of the study will be used to inform the TB care continuum in the Udupi district for necessary recommendations to the concerned authorities. The study will commence after an approval from the CTRI . A total of 245 TB patients who meet the inclusion criteria will be enrolled in the study after providing information regarding nature, purpose of the study. Written and signed informed consent will be obtained from the study participants and survey will be conducted in person at Tuberculosis Unit at Udupi district. Patients will be contacted prior and appointments will be obtained at their convenient date and time for the survey. Confidentiality and anonymity of the participants will be maintained by substituting codes for participant identifiers. The survey will be conducted by the principal investigator in the local language (Kannada) with the help of validated socio-demographic information and standard tools. General Health Questionnaire – 12 (GHQ-12) will be applied to all 245 TB patients, out of which those who scored ≥3 will be further qualified for application of QIDS – C – Clinician-rated Quick Inventory of Depressive Symptomatology, Hamilton Anxiety Rating Scale (HARS) and Perceived Stress Scale (PSS) questionnaire to assess the severity of depression, anxiety and stress respectively. The data collected will be with and can only be accessed by the PI . The data entry will be done and analyzed using SPSS Statistics 26.0.0 / Jamovi 2.2.2 and results will be stored securely for 3years

 
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