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CTRI Number  CTRI/2025/10/096732 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Utility of digital tool in diagnosing mental health disorders 
Scientific Title of Study   Evaluation & validation of mastishq 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Ranjan Avinash 
Designation  Professor and Head 
Affiliation  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun 
Address  HOD room, Department of Psychiatry Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun

Dehradun
UTTARANCHAL
248016
India 
Phone  9435703524  
Fax    
Email  pravinash@srhu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Priya Ranjan Avinash 
Designation  Professor and Head 
Affiliation  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun 
Address  HOD Room, Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun

Dehradun
UTTARANCHAL
248016
India 
Phone  9435703524  
Fax    
Email  pravinash@srhu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Priya Ranjan Avinash 
Designation  Professor and Head 
Affiliation  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun 
Address  HOD Room, Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun

Dehradun
UTTARANCHAL
248016
India 
Phone  9435703524  
Fax    
Email  pravinash@srhu.edu.in  
 
Source of Monetary or Material Support  
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, near Jollygrant Airport, Jollygrant, Dehradun, Uttarkahand, India, PIN - 248016 
 
Primary Sponsor  
Name  Priya Ranjan Avinash 
Address  Professor and Head of Department, Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Near Jollygrant airport, Jollygrant, Dehradun, Uttarakhand, India. PIN - 248016 
Type of Sponsor  Other [Individual - Prinicipal Investigator] 
 
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 
Priya Ranjan Avinash  Himalayan Institute of Medical Sciences  Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun
Dehradun
UTTARANCHAL 
9435703524

pravinash@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy controls 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The participants with or without mental
illness will be included after providing written informed consent.If the participants will not be able to give consent themselves, consent will be obtained from their relatives or caregivers on their behalf. Only the participants/relatives who can understand English will be included in the study. 
 
ExclusionCriteria 
Details  Anyone with sensory impairments that might impede the assessment will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the psychometric properties, namely, sensitivity, specificity, content validity, and interrater reliability of the MASTISHQ CoreScan Surface module  At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pravinash@srhu.edu.in].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Mental health disorders affect nearly one in eight people worldwide, representing a significant global public health concern. The burden is particularly high in low and middle income countries, where challenges such as limited healthcare infrastructure, inadequate workforce, cultural stigma, and low budget allocation severely constrain access to mental health care. Mental illnesses contribute more to years lived with disability than many major non communicable diseases, including heart disease and cancer. In India, the National Mental Health Survey reported a lifetime prevalence of 13.7 percent for mental health conditions estimating that nearly 150 million people require active mental health support. Despite this, the treatment gap remains between 70 and 92 percent across different disorders and population groups, illustrating the iceberg phenomenon where only a small portion of affected individuals receive diagnosis and treatment while the majority remain undetected and untreated. Conventional screening instruments are often time consuming, limited in diagnostic scope, and not adequately adapted to India’s cultural and linguistic diversity. These tools frequently miss subclinical symptoms and comorbid psychiatric conditions. The MASTISHQ or Mental health Assessment Tool for Integrated Screening and Health evaluation based Questionnaire module CoreScan Surface aims to address these limitations by providing a digital, scalable, and culturally sensitive approach to mental health screening. The tool comprises 217 items covering 25 common psychiatric conditions, including mood, anxiety, psychotic, personality, eating, and substance use disorders, along with neurodegenerative conditions such as dementia and Parkinson disease. It also assesses psychosocial domains including relationship difficulties, predisposition to mental illness, and occupational stress. This cross sectional observational study will be conducted in the Department of Psychiatry at the Himalayan Institute of Medical Sciences, Dehradun, following approval from the Institutional Ethics Committee. Participants with or without mental illness who are able to understand English and provide informed consent will be recruited. Those with sensory impairments that may interfere with the assessment will be excluded. Recruitment will be purposive, focusing on hospital based participants, and each assessment is expected to take approximately 45 to 60 minutes. Screening using the MASTISHQ CoreScan Surface will be administered by trained psychiatrists, and results will be compared with formal clinical diagnoses established using standard diagnostic criteria. To ensure objectivity, diagnostic verification will be carried out by independent psychiatrists who are not part of the tool development team. A minimum of 30 participants will be enrolled, and data will be analyzed using standard statistical methods. Diagnostic performance will be assessed through sensitivity, specificity, positive predictive value, and negative predictive value. Internal consistency will be measured using Cronbach alpha, inter rater reliability through Cohen kappa, and content validity by experienced psychiatrists evaluating the tool’s relevance, comprehensiveness, and cultural appropriateness. The study seeks to validate the MASTISHQ CoreScan Surface as a reliable, efficient, and culturally appropriate digital screening instrument that can facilitate early identification and management of mental health disorders within the Indian population.

 
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