| CTRI Number |
CTRI/2023/10/058924 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between the Experience of Own Bodily Sensations, Catching Emotions from Others,
and Difficulty in Understanding and Expressing Emotions among Caregivers of Individuals with
Schizophrenia |
|
Scientific Title of Study
|
Correlation between Interoceptive Sensibility, Emotional Contagion, and Alexithymia among
Caregivers of Persons with Schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riddhi Budhiraja |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8826850465 |
| Fax |
|
| Email |
riddhi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi,
Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Riddhi Budhiraja |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of Higher Education |
| 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 Shwetha TS |
Kasturba Medical College (KMC) |
Department of Clinical
Psychology, Manipal
College of Health
Professions, Manipal
Academy of Higher
Education
Udupi
KARNATAKA |
9880993080
shwetha.ts@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 |
Caregivers of individuals with schizophrenia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1 Caregivers of persons with schizophrenia 18 years and above
2 Caregivers living with and caring for the schizophrenic patient for more than 1 year |
|
| ExclusionCriteria |
| Details |
1 Individuals currently seeking treatment for or those who have any history of seeking treatment for a psychiatric or neurological disorder
2 Caregivers caring for more than one care recipient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the relationship between interoceptive
sensibility, emotional contagion, and alexithymia
among caregivers of persons with schizophrenia |
NA, this is not an interventional study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the patterns of interoceptive
sensibility, emotional contagion, & alexithymia
among caregivers of persons with schizophrenia. |
NA, this is not an interventional study. |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
28/10/2023 |
| 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="7"
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
|
This cross-sectional study aims to investigate the correlation between interoceptive sensibility,
emotional contagion, and alexithymia among caregivers of persons with schizophrenia. Individuals
satisfying the inclusion criteria will be approached in person and briefed about the study. Following
receipt of written consent, they will then be administered three
questionnaires: Multidimensional Assessment of Interoceptive Awareness (MAIA-2), Emotional
Contagion Scale (ECS), and Toronto Alexithymia Scale (TAS-20). Once the process of data
collection is over, data will then be entered into an excel sheet for analysis purposes. The results
will then be reported along with a discussion in light of the same. |