| CTRI Number |
CTRI/2026/01/102278 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Mental Health Problems Like Depression Anxiety and Stress Among First Year Students using a scale |
|
Scientific Title of Study
|
Prevalence of depression anxiety and stress among first year students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
SMBT College of Physiotherapy |
| Address |
Department of Electrotherapy and Electrodiagnosis
Nashik
MAHARASHTRA
422403
India |
| Phone |
8275014888 |
| Fax |
|
| Email |
drniharikagaikwad1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
SMBT College of Physiotherapy |
| Address |
Department of Electrotherapy and Electrodiagnosis
MAHARASHTRA
422403
India |
| Phone |
8275014888 |
| Fax |
|
| Email |
drniharikagaikwad1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niharika Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
SMBT College of Physiotherapy |
| Address |
Department of Electrotherapy and Electrodiagnosis
MAHARASHTRA
422403
India |
| Phone |
8275014888 |
| Fax |
|
| Email |
drniharikagaikwad1994@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMBT College of physiotherapy |
| Address |
Nandi hills Ghoti sinnar rd dhamangaon ghoti maharashtra India 422403 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Niharika Gaikwad |
SMBT College of Physiotherapy |
Department of electrotherapy and electrodiagnosis
Nashik
MAHARASHTRA |
8275014888
drniharikagaikwad1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Students who are enrolled in the first year of the college or institution
Male and female students aged 18 to 20 years
Students who are willing to participate in the study
Students who give written informed consent |
|
| ExclusionCriteria |
| Details |
Students who are not in the first year of the course
Students who are unwilling to participate or do not give consent
Students who are already diagnosed with a psychiatric illness and are on treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression Anxiety Stress Scale 21 items DASS 21 |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/02/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Depression anxiety and stress are common mental health problems among students especially during the first year of college due to academic pressure and adjustment to a new environment Poor mental well being can affect students academic performance social life and overall quality of life This study aims to understand how common symptoms of depression, anxiety, and stress are among first year college students Students who agree to participate will be asked to fill out a simple questionnaire related to their mental health Participation in the study is voluntary and the information collected will be kept confidential The findings of this study may help in early identification of mental health problems among first-year students and support the planning of counseling and mental health services for students |