| CTRI Number |
CTRI/2025/01/079640 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of an Indian psychology-based individual intervention to enhance personal qualities and wellbeing of emerging adults |
|
Scientific Title of Study
|
Evaluating the feasibility and acceptability of an Indian psychology-based individual intervention to enhance personal qualities and wellbeing of emerging adults with interpersonal difficulties |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Krishnan |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9895316496 |
| Fax |
|
| Email |
priyanka.krishnan@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Teddy Andrews JJ |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Social and Health Innovation, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
teddy.andrews@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Krishnan |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions, Manipal Academy of Higher Education
KARNATAKA
576104
India |
| Phone |
9895316496 |
| Fax |
|
| Email |
priyanka.krishnan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self,
Ms Priyanka Krishnan, Assistant Professor, Dept of Clinical Psychology, Manipal Collage of Health Professions,
Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Priyanka Krishnan |
| Address |
Assistant Professor, Department of Clinical Psychology, Manipal Collage of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi district, Karnataka
PIN: 576104 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 |
| Dr Anupama Vijayaraghavan |
Manipal Academy of Higher Education |
Department of Clinical Psychology,
Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA |
9739016983
v.anupama@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Interpersonal difficulties |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
This is a feasibility study |
| Intervention |
Psychosocial interventions
|
eight sessions will be planned on a weekly basis, each session of around 45 minutes to one hour will be given to the participants. The number of sessions may vary depends on the nature of problems. The intervention includes the detailed analysis of the interpersonal issues they are facing, psychoeducation regarding the intervention techniques based on Indian perspectives, interactive sessions focusing on the importance of ethics and values in personal relationships, breathing techniques, importance of lifestyle modification, techniques based on brahmaviharas focusing on loving kindness, compassion, sympathetic joy, equanimity and its applications in strengthening personal relations. They will be given instructions for out of the session assignments
The study duration is 4.5 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants who have relationship difficulties
Symptoms of mild anxiety or mild depression
Not meeting the criteria for ICD 11 diagnosis for major mental illness or Psychosis
|
|
| ExclusionCriteria |
| Details |
Psychosis or previous episodes of major mental illness, as per ICD 11
Individuals with a risk of suicide or history of suicidal attempts
Deliberate self-harm behaviours present
Participants born and brought up outside India
Individuals who are currently undergoing any psychological intervention
Individuals who are currently pursuing MSc and MPhil Clinical Psychology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Personal qualities and well being |
3 time points. One assessment before intervention, then after intervention and then after one month.
the intervention duration is 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhancing Wellbeing & decrease in interpersonal difficulties |
3 TIME POINTS. Before intervention, after intervention & after a one month period the assessments is repeated |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Aim: To evaluate the feasibility and acceptability of an Indian psychology-based individual intervention to enhance personal qualities and wellbeing of emerging adults with interpersonal difficulties
Objectives: Phase I: •To explore the perception, experiences and challenges of emerging adults in interpersonal relationships •To develop and validate an Indian psychology based individual intervention for enhancing personal qualities and wellbeing of emerging adults with interpersonal difficulties
Phase II: •To evaluate the feasibility and acceptability of Indian psychology-based individual intervention to enhance personal qualities and wellbeing of emerging adults with interpersonal difficulties |