| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pravinash@srhu.edu.in].
- 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.
- 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.
|