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CTRI Number  CTRI/2025/02/080159 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Exploring how does Acceptance and Commitment Therapy enhance Psychological well being among College students 
Scientific Title of Study   Effect Of Acceptance And Commitment Therapy On Emerging Adults with Poor Psychological Wellbeing  
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 Kailash Sureshkumar 
Designation  Professor and Head of the Department 
Affiliation  Chettinad Hospital and Research Institute 
Address  Department of Psychiatry Chettinad Hospital and Research Institute Kelambakkam 603 103 Chengalpattu District Chennai

Chennai
TAMIL NADU
603103
India 
Phone  9841227487  
Fax    
Email  kaidoc02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Athira Alex 
Designation  Research Scholar 
Affiliation  Chettinad Academy of Research and Education 
Address  Faculty of Allied Health Sciences Chettinad Academy of Research and Education Kelambakkam 603 103 Chengalpattu District Chennai

Chennai
TAMIL NADU
603103
India 
Phone  07909177934  
Fax    
Email  athiraalexx@gmail.com  
 
Details of Contact Person
Public Query  
Name  Athira Alex 
Designation  Research Scholar 
Affiliation  Chettinad Academy of Research and Education 
Address  Faculty of Allied Health Sciences Chettinad Academy of Research and Education Kelambakkam 603 103 Chengalpattu District Chennai

Chennai
TAMIL NADU
603103
India 
Phone  07909177934  
Fax    
Email  athiraalexx@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Academy of Research and Education Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam - 603 103, Chengalpattu District, Chennai, Tamil Nadu, India. 
 
Primary Sponsor  
Name  Athira Alex 
Address  Research Scholar Faculty of Allied Health Science Chettinad Academy of Research and Education Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam - 603 103, Chengalpattu District, Chennai, Tamil Nadu, India. Chettinad Academy of Research and Education Kelambakkam  
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 
Ms Athira Alex  St. Francis College  PB NO 3417 3rd Block 8th Main Koramangala Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 		 07909177934

athiraalexx@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE - CHETTINAD ACADEMY OF RESEARCH & EDUCATION  Approved 
NIL  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  POOR PSYCHOLOGICAL WELL BEING 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acceptance and Commitment Therapy  Acceptance and Commitment Therapy- A form of Psychotherapy developed by American Clinical psychologist Dr. Steven C Hayes The sessions will be conducted individually. One session per week has to be attended by the participants . The total number of session will be 10 . Each session will be last for 45 minutes to one hour 
Comparator Agent  No Treatment  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Age range of 18 to 25 years old
Individuals with poor Psychological wellbeing
Literacy in English language
Individuals available in in study location for a period of 3 months
Willingness to participate in ACT sessions and complete assessments 
 
ExclusionCriteria 
Details  Having a current diagnosis or undergoing treatment for any severe mental and physical illness or substance use disorder
Individuals who are currently enrolled in a college or university program as part - time.
Inability to understand or communicate in the language of the intervention and the assessments
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved Psychological well being- indicated by Psychological Well being scale by Ryff  12 week after the start of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Sustained improvement in Psychological well being  6 month after the start of intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/02/2025 
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="0"
Months="5"
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The present Randomized waitlist control study is aimed at assessing the efficacy of Acceptance and Commitment Therapy of emerging adults with poor Psychological Wellbeing. Initially the Psychological wellbeing will be assessed by Ryff’s Psychological Well being scale -(42 item version)during the baseline assessment.  Samples who falls into the category of poor psychological well being will be randomly selected and allocated to either into intervention group or into control group(waitlist control.). Individual who belongs to intervention group will be receiving the ACT intervention  - one session per week- through individual sessions. Each participant will receive 8 ACT sessions focusing on enhancing  well being. Upon the completion of the intervention, post treatment assessment will be done by using the same scale to assess the efficacy of Acceptance and Commitment Therapy in this population. Researcher hypothesize that ACT will significantly  enhance psychological wellbeing among emerging adults. The expected primary and secondary outcome of the study are  improved Psychological well being- indicated by Psychological Well being scale by Ryff  12 week after the intervention and and Sustained improvement in Psychological well being in 6 months after the intervention respectively.
 
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