FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092726 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Other 
Public Title of Study   Improving Mental Health and Wellbeing of Disaster First Responders through a Psychosocial Support Programme 
Scientific Title of Study   DEVELOPMENT AND EVALUATION OF PSYCHOSOCIAL WELLBEING PROGRAMME (PSWBP) FOR NATIONAL DISASTER RESPONSE FORCE (NDRF) FIRST RESPONDERS 
Trial Acronym  PSWBP NDRF  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KOATRI PUTESH 
Designation  PhD Scholar  
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychosocial Support in Disaster Management (DPSSDM) National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru pin 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9866951589  
Fax    
Email  puteshkotari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sanjeev Kumar Manikappa 
Designation  Associate Professor  
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychosocial Support in Disaster Management (DPSSDM) National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru pin 560029 India
National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru pin 560029 India
Bangalore
KARNATAKA
560029
India 
Phone  9866951589  
Fax    
Email  sanjeeva222@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KOATRI PUTESH 
Designation  PhD Scholar  
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychosocial Support in Disaster Management (DPSSDM) National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru pin 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9866951589  
Fax    
Email  puteshkotari@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences(NIMHANS) 
 
Primary Sponsor  
Name  MINISTRY OF SOCIAL JUSTICE AND EMPOWERMENT GOVT OF INDIA  
Address  National Scheduled Castes Finance and Development Corporation (A Government of India Undertaking) 14th Floor SCOPE Minar Core 1 2 North Tower Laxmi Nagar District Centre Laxmi Nagar Delhi 110 092  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suresh Kumar Reddy D   NDRF 10th Battalion RRC-3   RRC BLR MI Room-03 , Maruthi nagar , Yelhanka. Bengaluru,Pin-560064.
Bangalore
KARNATAKA 
9493035293

drdskr88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
National Institute of Mental Health and Neurosciences  Approved 
National disaster response force   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  National Disaster response force (NDRF) responders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Psychosocial wellbeing Programme   A week intervention will be provided to the experimental group, and after the three-month follow-up, the intervention will be provided to the waitlist group.  
Intervention  Psychosocial wellbeing Programme   The psychosocial well-being programme PSWBP is structured into four key modules, each designed to enhance the mental biological psychological and social well-being of National Disaster Response Force NDRF first responders. Module 1 Mental Health Education consists of four sessions of one hour each and covers the importance of well-being for first responders identification of common mental health challenges such as stress anxiety depression and PTSD and strategies for early recognition and help-seeking. This module is delivered through lectures group discussions and mind mapping exercises. Module 2 Biological Well-being also includes four one-hour sessions and addresses the biological effects of stress such as sleep disturbances fatigue and immune dysfunction and offers practical guidance on sleep hygiene physical exercise and nutrition. It is implemented using demonstrations group discussions and role plays. Module 3 Psychological Well-being includes four one-hour sessions focusing on psychological issues like acute stress and burnout. It introduces participants to mindfulness relaxation techniques and cognitive behavioral approaches using lectures role plays and interactive activities. Module 4 Social Well-being consists of four one-hour sessions that aim to strengthen interpersonal relationships and communication among colleagues and family members promote leadership skills and emphasize the role of family and community support. This module uses lectures brainstorming sessions group discussions and role plays. In total the intervention consists of sixteen sessions over sixteen hours utilizing diverse participatory and experiential learning methods. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  NDRF first responders who speak in English Hindi Telugu and Kannada
NDRF first responders who have participated at least one rescue operation
 
 
ExclusionCriteria 
Details  Those with severe psychiatric medical or neurological conditions that may interfere with the study will also be excluded
Those who are in long term leave or unavailable due to operational commitments will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant Improvement in resilience well-being quality of life coping and social support among the NDRF first responders  1 month to 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
National disaster first responders are able to identify psychosocial stressors both before and after a disaster   1 months to 6 months  
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/10/2025 
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="3"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjeeva222@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Background

Disaster is a social product The propensity for disaster is dependent upon the interplay between humans and their use of the physical and social world Within this perspective disaster can be seen in broader ecological terms to be an expression of the vulnerability of human society Vulnerability is contingent upon social preconditions The degree of vulnerability of a social system to a natural disaster is determined by the interaction of the physical properties of a disaster agent and the cultural social and psychological factors characteristic of the population occupying the specific location There is a spatial dimension to disaster occurrence which is delineated by the intersection of the occupied world and the boundaries within which a disaster agent can exert influence

Need of the Study

Disaster first responders particularly those in the National Disaster Response Force NDRF face significant mental health challenges due to regular exposure to traumatic events like deaths injuries and human suffering These stressors often lead to issues such as PTSD anxiety depression and burnout which affect their well-being and job performance With the increasing frequency and severity of climate-related and human-made disasters the demand for these responders is growing further exacerbating their mental health struggles Unfortunately these issues are often underreported and untreated due to stigma lack of awareness and organizational neglect

Given these challenges there is a clear need for a comprehensive psychosocial well-being programme PSWBP that addresses the unique mental health needs of disaster responders Such a program would focus on reducing stress enhancing quality of life resilience improving coping strategies and providing social support ultimately improving both their mental health and job performance This study aims to evaluate the effectiveness of a PSWBP for NDRF responders supporting their long-term well-being and enhancing their ability to manage the psychological demands of disaster response

Scope of the Study

The developed psychosocial well-being programme along with workbooks and IEC materials can help reduce stress and improve resilience well-being and quality of life among NDRF first responders It can be integrated into the regular training curriculum and implemented across all 18 NDRF battalions in India Additionally the programme can serve as a preparedness and mitigation strategy not only for NDRF responders but also for other disaster response teams including state forces firefighters police ambulance drivers EMS and volunteers The study findings could support policy changes to enhance psychosocial support for disaster first responders

Aim

The study aims to develop and evaluate the effectiveness of a psychosocial well-being programme PSWBP for National Disaster Response Force NDRF first responders

Objectives

1 To explore the psychosocial needs and concerns of the NDRF first responders
2 To develop and evaluate a Psychosocial Well-being Programme PSWBP for the NDRF first responders
3 To assess resilience well-being quality of life coping perceived stress and social support among NDRF first responders at varied intervals pre post and follow up
4 To test the effectiveness of the psychosocial well-being programme for NDRF first responders

Methodology

Research Design

The study would adopt a quasi-experimental research design with pre-test post-test and post-post follow up Assessment of the study participants will be carried out at three varied intervals under different conditions pre assessment post interventions assessment and post post assessment follow up

Universe

The universe of this study is the National Disaster Response Force NDRF a specialized unit responsible for disaster management in India There are 18 battalions spread across different regions of the country

Population

The study population would comprise the NDRF first responders of 10th Battalion stationed in Regional Response Centre 3 RRC 3 in Yelahanka Bengaluru Karnataka There are 120 first responders currently posted in the RRC 3 who would form the population of the current study

Sampling Method

Sampling for KII and FGD

Participants for key informant interviews KII and Focus Group Discussions FGDs will be selected using convenience sampling technique This is the first stage of the study and is used for understanding psychosocial needs and concerns of the NDRF first responders based on which a psychosocial well-being programme will be designed

Sampling for Main Study and Intervention Programme

The sample size for the current study was estimated under the within between repeated measures design with three measurements and two groups using a moderate effect size 03 Considering three repeated measurements the calculated minimum total sample size was 80 at five percent level of significance and 90 percent statistical power The final sample size N equals 92 was decided as 46 per group with an expected attrition rate of 15 percent at three-month follow up assessment However considering the total battalion size of 120 it is decided to recruit the entire battalion N equals 60 personnel for the intervention group and N equals 60 personnel for the control group For sample estimation G Power version 3197 was used

Sample Procedure

Simple random allocation technique will be adopted to recruit into experimental and control groups ensuring that every individual in the population has an equal chance of being chosen

Sample Size Estimation

The estimated sample size was 80 The entire population 120 first responders would be considered for the main study

Research Process

This study will be carried out mainly in four phases
1 Need assessment of National Disaster Response Force NDRF first responders and pre-assessment
2 Development and validation of the Psychosocial Well-being Programme PSWBP
3 Implementation of PSWBP and Post Assessment
4 Follow-up Assessment

Tools for Data Collection

1 Socio Demographic Sheet SDS
2 Kessler Psychological Distress Scale K10
3 The Perceived Stress Scale PSS
4 The Brief COPE Carver 1997
5 The Connor Davidson Resilience Scale CDRISC
6 WHOQOL BREF
7 The Subjective Well-being Inventory SUBI
8 Multidimensional Scale of Perceived Social Support MSPSS

Data Analysis

Qualitative data will be analysed through thematic analysis to identify themes to develop a psychosocial well-being programme PSWBP An audio recording of the key informant interviews and FGD will be transcribed Later codes will be designed to generate themes The thematic analysis will be done by using NVIVO or ATLASti software Consent for audio recording would be obtained from participants and confidentiality would be maintained Descriptive statistics such as measures of central tendency and dispersion would be carried out to describe the data

 
Close