| CTRI Number |
CTRI/2025/07/091184 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Culturally adapted acceptance and commitment therapy for resilience, flourishing and engagement in life for vulnerable Indian adolescents |
|
Scientific Title of Study
|
Culturally adapted acceptance and commitment therapy for Indian adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrina Bhullar |
| Designation |
PhD Scholar |
| Affiliation |
Postgraduate institute of medical education and research (PGIMER) |
| Address |
Department of psychiatry, Postgraduate institute of medical education and research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8875555884 |
| Fax |
8875555884 |
| Email |
bhullaramrina41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishan kumar |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research (PGIMER) |
| Address |
Department of psychiatry, Postgraduate institute of medical education and research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8607494950 |
| Fax |
8607494950 |
| Email |
keshusony@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrina Bhullar |
| Designation |
PhD Scholar |
| Affiliation |
Postgraduate institute of medical education and research (PGIMER) |
| Address |
Department of psychiatry, Postgraduate institute of medical education and research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8875555884 |
| Fax |
8875555884 |
| Email |
bhullaramrina41@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission (UGC-JRF) |
|
|
Primary Sponsor
|
| Name |
University Grants Commission (UGC) |
| Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nidhi Goyal |
Government model senior secondary schools |
Director education, Education department, Jan Marg, sector 9-D, Chandigarh
Chandigarh
CHANDIGARH |
9646139942
ssautchd@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indian adolescents vulnerable of developing mental disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acceptance and commitment therapy |
Psychological intervention for adolescents |
| Comparator Agent |
Control group |
No intervention will be given to this group |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Absence of psychiatric disorders
Age: 13 to 18 years
Enrolled in a senior secondary school in Chandigarh
Able to read and write in English, Hindi, and Punjabi
Informed assent from adolescents and consent from parents |
|
| ExclusionCriteria |
| Details |
Presence of a psychiatric disorder
Presence of medically diagnosable or self-reported uncorrected visual or auditory impairment causing communication difficulties.
Not giving assent and consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Academic performance
2. Flourishing
3. Resilience
4. Perceived stress |
1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anxiety problems
2. Depressive problems
3. Attention deficit/hyperactivity problems
4. Oppositional defiant problems
5. Conduct problems |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/08/2025 |
| 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="6"
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
|
The research focuses on culturally adapting Acceptance and Commitment Therapy (ACT), specifically the DNA-V model, for Indian adolescents at risk of mental health difficulties. Using the Ecological Validity Model, conduct qualitative research through focus group discussions with adolescents and other stakeholders to explore the cultural relevance, comprehensibility, and resonance of ACT’s metaphors, techniques, and delivery methods. The insights from this formative phase inform the adaptation of the intervention, which I plan to evaluate through a randomized controlled trial (RCT). The RCT aims to assess the effectiveness of the adapted ACT module in improving flourishing, psychological resilience, and academic and co-curricular engagement among Indian school-going adolescents over time. |