FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089769 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Study to assess the effectiveness of Mental Health Enhancement program 
Scientific Title of Study   An Experimental study to evaluate the effectiveness of Mental Health Enhancement Programme on Employee-wellbeing, Employee engagement and Resilience among du workers in selected industries of Punjab.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manu Kohli 
Designation  Associate Professor 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University, Punjab
Chitkara School of Health Sciences, Chitkara University, Punjab
Patiala
PUNJAB
140401
India 
Phone  09501966684  
Fax    
Email  manu.kohli@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Manu Kohli 
Designation  Associate Professor 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University, Punjab
Chitkara School of Health Sciences, Chitkara University, Punjab
Patiala
PUNJAB
140401
India 
Phone  09501966684  
Fax    
Email  manu.kohli@chitkara.edu.in  
 
Details of Contact Person
Public Query  
Name  Manu Kohli 
Designation  Associate Professor 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University, Punjab
Chitkara School of Health Sciences, Chitkara University, Punjab
Patiala
PUNJAB
140401
India 
Phone  09501966684  
Fax    
Email  manu.kohli@chitkara.edu.in  
 
Source of Monetary or Material Support  
Aggarwal Packages D 24, Focal Point, rajpura, 140401 
Champion Engineering Industries, D-22, Focal Point, Rajpura, 140401 
 
Primary Sponsor  
Name  Manu Kohli 
Address  Associate Professor, Chitkara School of Health Sciences, Chitkara University, Punjab, 140401 
Type of Sponsor  Other [Private University] 
 
Details of Secondary Sponsor  
Name  Address 
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 
Susheel Kumar  1. Aggarwal packages  D24, Focal Point, Rajpura
Patiala
PUNJAB 		 9814053551

aggarwalpackrjp@gmail.com 
Er Jatinder Singh Sandhu  2.Champion Engg.Industries  D22, Focal Point, Rajpura
Patiala
PUNJAB 		 9814348345

champion_engineering@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Aggarwal packages  No Objection Certificate 
Champion Engineering Industries  No Objection Certificate 
Institutional Human Ethical Committee, Chitkara University, Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy employees working in industries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mental Health Enhancement Programme  Mental Health Enhancement Programme consists of 4-week sessions to improve the Employee Engagement, Resilience, and Employee Well-Being among the adult workers in industries. Intervention will be given on a group basis. Each session will be of 30 minutes duration, comprised of modules on stress Management, Relaxation Technique (Deep Breathing Exercises), Mindfulness and Meditation, CBT(Cognitive Behavior Therapy), Emotional Intelligence and Resilience, Peer Support Groups, effective Communication, and Goal-Setting. The order of the modules will be fixed and its activation will occur successively. The session content will be supported by visual materials, purposive activities,role playing scenarios, homework and use of progrss reporting  
Comparator Agent  Normal Routine of the industry  The control group will follow the normal routine of the industry and investigator will plan a group meeting once a month informally to know about their well-being. After the posttest the Mental Health Enhancement Programme will be administered to the control group also 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Employee currently employed in selected industries for at least 6 months. 
 
ExclusionCriteria 
Details  Participants who will have severe mental health conditions requiring immediate clinical
intervention or taking any medications for mental illness.
Participants who will be on short-term assignments.
Participants who already enrolled in a mental health or employee well being program.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improve employee well-being, employee engagement and resilience.  Baseline, and at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   01/12/2025 
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="1"
Months="5"
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    
Close