| CTRI Number |
CTRI/2024/10/075547 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Difficult Childhood Experiences on Young Adults’ Self-Care and Compassion for Their Bodies |
|
Scientific Title of Study
|
The Relationship Between Adverse Childhood Experiences, Body Investment and Body Compassion in Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanah Arora |
| Designation |
MSc Clinical Psychology Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9643842638 |
| Fax |
|
| Email |
sanah.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Aparna Daga |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9748655646 |
| Fax |
|
| Email |
daga.aparna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priyesh C |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9600300099 |
| Fax |
|
| Email |
c.priyesh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal, Karnataka- 576104 India |
|
|
Primary Sponsor
|
| Name |
Sanah Arora |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE, 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 |
| Dr Sivapriya Vaidyanathan |
Kasturba Hospital, Manipal |
Department of Psychiatry, Room no.11, Kasturba Hospital, Manipal
Udupi, Hebri Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
6382339965
sivapriya.v@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
presence of adverse childhood experiences as per ACE-Q |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Adverse Childhood Experiences -Questionnaire score at least 1. |
|
| ExclusionCriteria |
| Details |
Individuals undergoing structured psychotherapy.
Individuals taking Psychiatric medicines.
Individuals with major medical illness
Individuals without history of Adverse Childhood Experience |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relationship between Adverse Childhood Experiences and Body Investment
and Body Compassion.
using,
Body Investment Scale (BIS)
Body Compassion Scale (BCS) |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship between ACE subtypes with regards to body investment and body compassion. |
baseline |
Relationship between first age of traumatization and duration of adverse
childhood experiences on body investment and body compassion |
baseline |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/11/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim of the Study: To study the relationship between Adverse Childhood Experiences, Body Investment
and Body Compassion in young adults.
Primary objective: To study the correlation between body investment and body compassion in the context of
adverse childhood experiences.
Secondary objective(s): 1.Study the influence of ACE on individuals’ attitudes and behaviours related to body
investment, considering its components and overall scores. 2.Examine how adverse childhood experiences are associated with individuals’ levels of
body compassion. 3.Explore the effect of ACE subtypes, the first age of traumatization and duration of adverse
childhood experiences on the relationship with body investment and body compassion.
The study duration is from June 2024 to March 2025. |