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CTRI Number  CTRI/2024/07/071222 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Acceptance and Commitment Therapy Workshop to Promote Mental Health Support in College Students. To enhance the awareness of psychological help-seeking behaviour in students. 
Scientific Title of Study   A Single Session Workshop using Principles of Acceptance and Commitment Therapy for Promoting Psychological Help-Seeking in Students of Higher Education Institutions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikas Kumar 
Designation  PhD Research Scholar 
Affiliation  Kazi Nazrul University 
Address  Room No. - 208, Bidya-Charcha Bhavan, Department of Applied Psychology, Kazi Nazrul University

Barddhaman
WEST BENGAL
713340
India 
Phone  9559170575  
Fax    
Email  ku.vikasbhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shuvabrata Poddar 
Designation  Assistant Professor 
Affiliation  Kazi Nazrul University 
Address  Room No. - 208, Bidya-Charcha Bhavan, Department of Applied Psychology, Kazi Nazrul University

Barddhaman
WEST BENGAL
713340
India 
Phone  7549089680  
Fax    
Email  shuvabrata.poddar@knu.ac.in  
 
Details of Contact Person
Public Query  
Name  Vikas Kumar 
Designation  PhD Research Scholar 
Affiliation  Kazi Nazrul University 
Address  Room No. - 208, Bidya-Charcha Bhavan, Department of Applied Psychology, Kazi Nazrul University

Barddhaman
WEST BENGAL
713340
India 
Phone  9559170575  
Fax    
Email  ku.vikasbhu@gmail.com  
 
Source of Monetary or Material Support  
Kazi Nazrul University, Domohani Railway Colony, Asansol, West Bengal, 713340, India. 
 
Primary Sponsor  
Name  Mr Vikas Kumar 
Address  Room No. - 208, Bidya-Charcha Bhavan, Department of Applied Psychology, Kazi Nazrul University, Domohani Railway Colony, Asansol, West Bengal 713340, India. 
Type of Sponsor  Other [Self] 
 
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 
Vikas Kumar  Kazi Nazrul University, Asansol  Room No. - 208, Bidya-Charcha Bhavan, Department of Applied Psychology, Kazi Nazrul University, Asansol
Barddhaman
WEST BENGAL 		 9559170575

ku.vikasbhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee, Kazi Nazrul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal and Healthy Students of Colleges and Universities. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acceptance and Commitment Therapy  Duration of Intervention- 90-minutes. A one day single session workshop based on Acceptance and Commitment Therapy (ACT) typically aims to introduce participants to ACT core principles and techniques. Workshop Objectives: - Introduce the six core processes of ACT: cognitive defusion, acceptance, contact with the present moment, self-as-context, values, and committed action. - Provide experiential exercises to illustrate these concepts. - Equip participants with practical tools to apply ACT principles in their daily lives. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) Students currently enrolled in higher education institutions,
2) Participants in the age group of 18-30 years,
3) Participants will be selected from the eastern region of India,
4) Participants who can read and write English and who can communicate in one of the following languages: English and Hindi.
5) All gender. 
 
ExclusionCriteria 
Details  1) History of chronic or diagnosable medical/neurological illness.
2) Severe psychological distress that requires immediate intervention, as determined by a
preliminary screening. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increased Psychological Help-Seeking:
Participants will demonstrate a greater willingness to seek psychological help when needed, which is reflected in an increased number of students reaching out for counselling services. 		 Baseline, Post assessment after Intervention on the same day, and after 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Enhanced Psychological Flexibility:
Participants will show improved ability to adapt to challenging thoughts and emotions without unnecessary avoidance or struggle, measured through self-reported scales of psychological flexibility.

2) Reduced Stigma Toward Mental Health:
Participants will exhibit reduced stigmatizing attitudes towards mental health issues, as assessed by changes in stigma-related survey responses before and after the workshop. 		 One month 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2024 
Date of Study Completion (India) 30/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Clinical Study Report
    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 [ku.vikasbhu@gmail.com].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 31-07-2029?
    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  

The study aims to evaluate the effectiveness of a single-session workshop based on Acceptance and Commitment Therapy (ACT) in reducing stigma associated with seeking psychological help and promoting help-seeking behavior among higher education students. Objectives include assessing the workshop’s impact on reducing self-stigma, increasing intentions to seek help, and investigating psychological flexibility as a mediator. Pre- and post-workshop comparisons will determine the specific effects of the intervention. The hypotheses test for significant differences in self-stigma, help-seeking intentions, and psychological flexibility. A prospective exploratory trial with a pretest-posttest design will be used, involving 400 participants from higher education institutions in eastern India, aged 18-30, who meet inclusion criteria. Exclusion criteria include chronic medical/neurological illnesses and severe psychological distress. Tools include informed consent, demographic data sheets, and several scales to measure stigma, psychological flexibility, and help-seeking attitudes. The intervention consists of a 90-minute ACT workshop conducted by a trained therapist, featuring psychoeducation, cognitive defusion exercises, values clarification, and commitment exercises.

 
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