| CTRI Number |
CTRI/2019/08/020884 [Registered on: 26/08/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method study with quantitative strand followed by qualitative strand |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Self-Compassion and Self-Esteem in young adults |
|
Scientific Title of Study
|
Self-Compassion among Young Adults and its Relationship with Self-Esteem |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Mishra |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9910756823 |
| Fax |
|
| Email |
apoorva3mishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syam KRavindran |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
567104
India |
| Phone |
7204106410 |
| Fax |
|
| Email |
syam.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Syam KRavindran |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
567104
India |
| Phone |
7204106410 |
| Fax |
|
| Email |
syam.kr@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education
Manipal
Karnataka
576104 |
|
|
Primary Sponsor
|
| Name |
Apoorva Mishra |
| Address |
Department of Clinical Psychology,
Manipal College of Health Professions,
Manipal Academy of higher education,
Madhav nagar
Manipal
Karnataka
576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Apoorva Mishra |
Manipal Academy of Higher Education |
Couselling room-1st floor,
Manipal college of Health Professions,
MAHE,
Manipal
Udupi
KARNATAKA |
9910756823
apoorva3mishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants need to be between age range of 18 to 24 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1)Age range- 18- 24 years
2)Only those who obtain a high score (91-130) on self -compassion scale to be included in phase II.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Categories that emerge from the interview |
August 2019 to March 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Mixed Method Study carried out in two phases. Phase I involves assessing participants’ levels of self -esteem and self-compassion through two questionnaires. Post analysis of data obtained in Phase I, those participants who score high on self-compassion scale would be included in the Phase II of the study. Phase II includes an in-depth interview with participants regarding their high self-compassion. The interview will be recorded using a voice recorder and the recorded data will be further transcribed and will be subjected to qualitative data analysis. |