| CTRI Number |
CTRI/2024/06/068766 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Insights into Mental Health: Unveiling Student and LGBT Well-being through Language - A Novel Interventional Approach to Pre-screen Mental Health via Writing Analysis. |
|
Scientific Title of Study
|
Exploring Mental Health Status in a Selected Population: A corpus analysis combining Forensic Linguistics and Psychology - a Mixed Method Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thamizh Mani R |
| Designation |
Ph.D. Student / Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal / Manipal Academy of Higher Education |
| Address |
Department of Forensic Medicine and Toxicology, Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Karnataka , India.
KARNATAKA
576104
India |
| Phone |
7539910789 |
| Fax |
|
| Email |
thamizhmani36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Palimar |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal / Manipal Academy of Higher Education |
| Address |
Department of Forensic Medicine and Toxicology, Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Karnataka , India.
KARNATAKA
576104
India |
| Phone |
9886340969 |
| Fax |
|
| Email |
vikram.palimar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Thamizh Mani R |
| Designation |
Ph.D. Student / Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal / Manipal Academy of Higher Education |
| Address |
Department of Forensic Medicine and Toxicology, Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Karnataka , India.
KARNATAKA
576104
India |
| Phone |
7539910789 |
| Fax |
|
| Email |
thamizhmani36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Source of Funding: Self Funded.
Infra Structure Support:
Department of Forensic Medicine and Toxicology,
Kasturba Medical College,
Manipal Academy of Higher Education (MAHE),
Tiger Circle, Madhav Nagar, Eshwar Nagar,
Manipal , Udupi, Karnataka,
India - 576 104. |
|
|
Primary Sponsor
|
| Name |
Thamizh Mani R |
| Address |
Department of Forensic Medicine and Toxicology, Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Karnataka , India
Pin code: 576104. |
| Type of Sponsor |
Other [Self - funded] |
|
|
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 |
| Thamizh Mani R |
Kasturba Medical College |
Second Floor, Department of Forensic Medicine and Toxicology, Biochemistry Building, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104.
Udupi
KARNATAKA |
7539910789
thamizhmani36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental health Conditions - Depression and Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Observational Cross-Sectional Study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
STUDENTS POPULATION:
1.Volunteers who are interested in the study who are above the age of 18 and below the age of 35 are recruited for this study.
LGBT POPULATION:
1.LGBT Volunteers who are interested in the study who are above the age of 18 and below the age of 35 are recruited for this study.
2.LGBT Volunteers, who are literate, are included in this study since the study requires an educated population to understand the research to a better extent.
3.Volunteers who can communicate in English are included in this study.
|
|
| ExclusionCriteria |
| Details |
STUDENT POPULATION:
1.Students who are not interested in the study will not be involved in this research.
2.Volunteers who are having Neurodevelopmental disorders will be excluded from the study.
LGBT POPULATION:
1.LGBT individuals who are illiterate or literate but cannot understand the study will be excluded.
2.Volunteers who cannot communicate in English are excluded in this study.
3.Volunteers who are having Neurodevelopmental disorders 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 |
1. Introducing a novel method to screen students mental health via regular writing analysis, aiding their mental well-being needs.
2. Creating a reliable method for mental health assessment using forensic linguistic analysis.
3. Exploring corpus analysis for evaluating psychological distress in legal and investigative settings. |
The research is a cross-sectional observational study. Data is collected at a single point in time, not longitudinally. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improved early intervention strategies for mental health professionals.
2.Enhanced mental health screening methods in various settings, including clinical, educational, & occupational. |
The research is a cross-sectional observational study. Data is collected at a single point in time, not longitudinally. |
|
|
Target Sample Size
|
Total Sample Size="435"
Sample Size from India="435"
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)
|
26/08/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
The protocol’s primary
purpose is to investigate a specific population’s mental health status using a
mixed-methods approach integrating qualitative and quantitative analyses. The
study aims to combine disciplines such as Forensic Linguistics, Psychology,
Machine Learning (ML), and Natural Language Processing (NLP) to understand
mental health landscapes. The study seeks to develop targeted interventions and
support services to promote mental well-being by examining linguistic patterns
and psychological factors and leveraging AI-based technologies. The hypothesis
is that by employing interdisciplinary approaches and advanced technologies, a
deeper understanding of mental health issues within the selected population can
be achieved, leading to more effective interventions. |