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CTRI Number  CTRI/2025/11/098196 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   How creating art can be beneficial for students to identify, manage their emotions, become stronger and feel better. 
Scientific Title of Study   Effectiveness of mindfulness- based arts therapy on emotional regulation, resilience and psychological well-being among university students: A pre-post group intervention 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  Megha Sri Sri Mal 
Designation  Trainee Clinical Psychologist 
Affiliation  Rashtriya Raksha University 
Address  Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Rashtriya Raksha University, Lavad, Dahegam, Gandhinagar-382305, Gujarat, India.
Gandhinagar
GUJARAT
382305
India 
Phone  9662038457  
Fax  NA  
Email  srisrimalmegha011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Sayan Bandyopadhyay 
Designation  Assistant Professor (Clinical Psychology) 
Affiliation  Rashtriya Raksha University 
Address  Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Gandhinagar
GUJARAT
382305
India 
Phone  9531795322  
Fax  NA  
Email  sayan.banerjee@rru.ac.in  
 
Details of Contact Person
Public Query  
Name  Mr Sayan Bandyopadhyay 
Designation  Assistant Professor (Clinical Psychology) 
Affiliation  Rashtriya Raksha University 
Address  Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Gandhinagar
GUJARAT
382305
India 
Phone  9531795322  
Fax  NA  
Email  sayan.banerjee@rru.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Megha Sri Sri Mal 
Address  Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India. 
Type of Sponsor  Other [Self- Megha Sri Sri Mal] 
 
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 
Megha Sri Sri Mal  Rashtriya Raksha University  Department of Clinical Psychology, School of Behavioural Science and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam Road, Gandhinagar-382305, Gujarat, India.
Gandhinagar
GUJARAT 		 9662038457

24mphilcp004@student.rru.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE, RASHTRIYA RAKSHA UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  EMOTIONAL DYSREGULATION, REDUCED RESILIENCE AND PSYCHOLOGICAL WELL BEING 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mindfulness-based art therapy (8 sessions, weekly once)  Mindfulness-based art therapy is a fairly new therapeutic approach that has been introduced by writer and psychologist Laury Rappaport. MBAT merges the principles and techniques of mindfulness with creative art therapy ( Rappaport, 2008). A total of 8 MBAT sessions will be conducted weekly- one session.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  The study will include university students aged 18 to 28 years who have mild
to moderate difficulties in managing their emotions and show lower levels of resilience and
well-being. They should also be able to understand and communicate in either English or Hindi
to take part in the sessions and assessments.  
 
ExclusionCriteria 
Details  The study will exclude students who are currently experiencing an acute psychiatric crisis or have neurological difficulties, as reported by themselves or referred by faculty. It will also exclude those who are already taking part in ongoing psychotherapy or another intervention trial.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
change in emotional regulation, resilience, and psychological well-being  baseline, 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
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  

University students are exposed to increased academic, social, and personal stressors that can adversely affect their emotional regulation abilities, resilience, and overall psychological well-being. Although mindfulness-based art therapy (MBAT) has been found effective for stress reduction, existing research is limited and has not simultaneously examined its impact on emotional regulation, resilience, and psychological well-being in university populations. Thus, the present study aims to evaluate the effectiveness of MBAT delivered in a group therapy format on these three psychological outcomes among college students. A pre–post design will be used with 15 participants recruited through purposive sampling. Measures will include the Difficulties in Emotion Regulation Scale (DERS), the Connor-Davidson Resilience Scale, and Ryff’s Psychological Well-Being Scale. Participants will undergo eight sessions of MBAT, after which the same measures will be re-administered to assess change.

 
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