| CTRI Number |
CTRI/2026/04/109045 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EFFECTIVENESS OF CAPACITY BUILDING MENTAL HEALTH FIRST AID PROGRAM] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of mental health first aid capacity building training program on knowledge, attitude, confidence and referral among Auxiliary Nurse Midwives and Multipurpose health workers: A randomized control study. |
|
Scientific Title of Study
|
Impact of mental health first aid capacity building among ANM and MPHW on ability to identify,respond to and refer mental health issues in Primary Health Centres:-A randomized control 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 |
Mrs. Shedi Dias |
| Designation |
PhD STUDENT (Part-time External) |
| Affiliation |
KAHER UNIVERSITY |
| Address |
Department of Mental Health Nursing
KAHER INSTITUTE OF NURSING SCIENCES,BELAGAVI
JNMC BELAGAVI
Belgaum
KARNATAKA
590001
India |
| Phone |
09923887141 |
| Fax |
|
| Email |
shedididias@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veereshkumar Nandagoan |
| Designation |
PRINCIPAL and PROFESSOR, DEPARTMENT OF MENTAL HEALTH NURSING. |
| Affiliation |
KAHER UNIVERSITY |
| Address |
KAHER INSTITUTE OF NURSING SCIENCES,BELAGAVI
JNMC, Nehru Nagar.
Belgaum
KARNATAKA
590001
India |
| Phone |
09844971345 |
| Fax |
|
| Email |
principalklenursingbgv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Veereshkumar Nandagoan |
| Designation |
Principal and Professor, Department Of Mental Health Nursing. |
| Affiliation |
INSTITUTE OF NURSING EDUCATION, BAMBOLIM |
| Address |
KAHER INSTITUTE OF NURSING SCIENCES,BELAGAVI
JNMC,BELAGAVI
Belgaum
KARNATAKA
590001
India |
| Phone |
09844971345 |
| Fax |
|
| Email |
principalklenursingbgv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sandesh Madkaikar Chief Medical Officer NCDC |
| Address |
DIRECTORATE OF HEALTH SERVICES PANAJI GOA |
| Type of Sponsor |
Other [JCI Ponda, NGO] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JCI PONDA |
PONDA GOA |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVeereshkumar Nandagoan |
KLE BELGAVI |
KAHER KLE INSTITUTE OF NURSING SCIENCES BELGAVI
Belgaum
KARNATAKA |
09844971345
principalklenursingbgv@gmail.com |
| SHEDI DIAS |
PRIMARY HEALTH CENTRES OF GOA |
Campal, Panaji Goa
North Goa
GOA |
09923887141
shedidias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEACH AND ETHICS COMMITTEE KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z000.6 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mental health first aid capacity building program |
Online Program of 90 Days as per participants convenience
7 Modules
Platform: Delivered via secure LMS(Learning Management System)online program
Duration: 4.5 hours, spread over 90 days
Content: MODULE 1-MODULE 7
TIME SLOTS: Convenience of participants
Mode of Accessing: Student login id will be given to participants
Mode: Self-paced modules.
Pre test and Post Test will be conducted for Experimental Group
Comparator group: Mental Hygiene Program of One Hour will be administered through online LMS portal |
| Comparator Agent |
Mental Hygiene Program |
One hour Program
Delivered via LMS portal on
diet
exercises
Sleep |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nurses working at primary health centers
Registered nurses
Willing to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Nurses not willing to participate in the study
On long leave or unavailable for follow-up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Mental health knowledge (validated questionnaire)
Attitude towards mental illness{validated scale}
Self-confidence in delivering mental health support (Likert scale/self-efficacy tool)
|
Measurement points:
Baseline (Pre-training)
Post-intervention (1 week after training)
Follow-up (3 months after training)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
06/05/2026 |
| 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="2"
Months="2"
Days="6" |
|
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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included SHEDIDIAS@GMAIL.COM).
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
- In the last few years around ten years increase in importance to care for mental health issues have been scrupulously identified as essential in global entire scale. according to the most important report on global mental health WHO report the movement has been started to address mental health issues by making the general population more aware through education information and communication. PHC and CHC are entry points in rural health care just experiencing difficulty psychological problems and not reporting can have toll on mental health of individuals. Also available Psychiatrist is bleak therefore training in capacity building for ANM And MPHW is inevitably essential to point and pick confidently mental ill population and refer for quality service in spite of the stigma associated.
|