| CTRI Number |
CTRI/2025/02/080887 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
RURAL MENTAL HEALTH PROGRAM FOR THE POPULATION OF MUNSIYARI BLOCK IN UTTARAKHAND STATE |
|
Scientific Title of Study
|
NIMHANS-AHT Comprehensive Mental Health Action Program for Rural Communities (NAMAN) |
| 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 Vikram Singh Rawat |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room No.016412 Department of Psychiatry, All India Institute of Medical Sciences Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911546 |
| Fax |
|
| Email |
vikram.psyc@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Singh Rawat |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room No.016412 Department of Psychiatry, All India Institute of Medical Sciences Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911546 |
| Fax |
|
| Email |
vikram.psyc@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Singh Rawat |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room No.016412 Department of Psychiatry, All India Institute of Medical Sciences Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911546 |
| Fax |
|
| Email |
vikram.psyc@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Ashraya Hastha Trust. Krutaarth, No. 2 (37), 15th Cross, Patalamma Temple Road, 3rd Block - Jayanagar, Bangalore 560 011. |
|
|
Primary Sponsor
|
| Name |
Ashraya Hastha Trust |
| Address |
Krutaarth, No. 2 (37) 15th Cross Patalamma Temple Road 3rd Block - Jayanagar Bangalore 560 011. |
| Type of Sponsor |
Other [Non-Governmental Organization] |
|
|
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 Vikram Singh Rawat |
Community Health Centre, Munsiyari |
Munsiyari District Pithoragarh State Uttaranchal. Room No. 1. NAMAN Clinic
Pithoragarh
UTTARANCHAL |
7055911546
vikram.psyc@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mental health related services for every person of the community. |
Prevention and Promotional activities for every person of the community. That will include awareness activities, treatment of persons with mental illness, and rehabilitation. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
We will include patients and healthy participants of all the age groups |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mental health services in the community will be enhanced. People will be able to get the affordable mental health services. |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="39000"
Sample Size from India="39000"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="2"
Months="0"
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
|
This program envision to implement a taluka level rural community mental health service following a hub-and-spoke model of service delivery, NIMHANS, Bengaluru, serves as the hub, with a sub-hub at AIIMS, Rishikesh, to implement the taluka mental health services to Belur (A taluk in the Hassan district of the south Indian state of Karnataka) and Munsiyari (A taluka in the Pithoragarh district in the north Indian state of Uttarakhand). This program will be implemented in four phases: (1) Resource building, (2) Situational Analysis, (3) Intervention, and (4) Evaluation. Activities under each of these phases may overlap in the timeline, wherever feasible, to accelerate the speed of program. Goals of the program: - 1. To screen 100% of individual for mental health conditions, 50% of them will receive promotive and preventive mental health services. 2. Appropriate interventions to the 100% of those who screened positive for mental health conditions. 3. To develop a replicable model which can be implemented in other parts of the country (the project will be developing guidelines for block-level program implementation). |