| CTRI Number |
CTRI/2024/10/074556 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Views of people with mental illnes about their family role in their day- to-day activities |
|
Scientific Title of Study
|
Family role in Occupational Functioning:Experiences of Individuals with Severe Mental Illness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tharani V |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi KARNATAKA 576104 India |
| Phone |
9095013167 |
| Fax |
|
| Email |
tharanivenkatachalam55@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vinita A Acharya |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi KARNATAKA 576104 India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Vinita A Acharya |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi KARNATAKA 576104 India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Manipal Academy of Higher, Education,Manipal- 576104. |
|
|
Primary Sponsor
|
| Name |
Tharani V |
| Address |
Department of Occupational Therapy,Manipal Collge of Health Professions,Manipal Academy of Higher Education, Manipal-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 |
| Tharani V |
Kasturba Hospital |
Psychosocial Rehabilitation Room,3rd floor, CTC Block, Department of Occupational therapy,Kasturba Hospital, Udupi- Herbi Road, Madhav Nagar,Manipal- 576104 Udupi KARNATAKA |
9095013167
tharanivenkatachlam55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee- 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F31||Bipolar disorder, (2) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Stable Individuals diagnosed with SMI for more than a year
- English or Kannada speaking individuals diagnosed with SMI
- Age: 18 –65 years
- Individuals with SMI who are living or have lived with family (blood related) for at least 2 years
after diagnosis |
|
| ExclusionCriteria |
| Details |
• Acute or aggressive individuals with severe mental illness are excluded
• Dementia, delirium and other neuropsychiatric disorders are excluded
• Individuals with SMI who are heavily medicated will be excluded
• Individuals with SMI who gets symptomatic during the interview session will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Family influence on Occupational Functioning in Individuals with Severe Mental Illness |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occupational Functioning of Individuals with Severe Mental Illness |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="13" Sample Size from India="13"
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)
|
02/10/2024 |
| 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="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
|
Aim:To explore the experiences of the individuals with SMI about their family’s role in their
occupational functioning.
Justification for Study: Occupational functioning is known to be affected in individuals with SMI. Being productive is
important among individuals with SMI, which is affected by multiple factors such as peers,
workplace including families.Indian families are collectivistic in nature, supports one another in times of crisis and enhances
their family members wellbeing. Although families are often supportive, how they are perceived by
the individuals with SMI is not clear. Lack of insight about the experiences of individuals with SMI can lead to mismatch between
the interventions provided by occupational therapists and the actual desires of the individual.
Therefore, it is important to explore the experiences of individuals with SMI to provide client
specific interventions and enhance their overall functioning.
Detailed description of the procedure: The proposal will be presented to the Institutional Research Committee (IRC). The interview guide
consisting of main questions, prompts and probes based on the conceptual framework will be prepared
by the researcher. The interview guide will include a variety of open-ended questions designed to
prompt the participants to discuss their experiences in detail. The interview guide will be validated by
subject experts. Permission will be obtained from the Head of the Department of Psychiatry and
Kasturba Hospital Medical Superintendent before IEC. After the approval, the necessary documents
will be submitted to IEC for further permission and the CTRI will be registered. The researcher will
undergo basic training in qualitative research (online course and practice interviews) and data
collection methods. The participants will be recruited from the Department of Psychiatry of KMC
Hospital. The study’s purpose will be discussed with the participants, and informed consent will be
obtained from participants and caregivers along with the interview guide and consent form. Individual
in-depth interviews will be conducted in the occupational therapy department in KMC hospital by the
researcher, based on the interview guide, and the data will be audio recorded and the field notes will
be taken. During the interview the participants will be given enough time to think and share their
experiences. The interview is expected to be around 45-60 mins, with extra time allowed if needed.
The participants will be provided with break time, if necessary. With the participant’s permission, audio
recordings will be made of the interview. The study will be conducted until the theoretical data
saturation occurs, that is the participants will be recruited, until no new information is obtained from the
interviews. The interviews will be transcribed verbatim in English / Kannada. The Kannada interviews
will be translated into English. The transcribed interviews will be thematically analyzed. Finally, the
dissertation and manuscript writing, and submissions will be completed.
Data analysis: The data obtained from interviews will be transcribed verbatim in Kannada /
English and translated to English. The obtained data will be analyzed by using thematic analysis
approach for identifying, analyzing and interpreting pattern of meanings (themes). Initially the transcripts
will be read and re-read again to understand it and initial codes will be generated from the obtained
data. Potential themes will be searched with the codes identified and will be reviewed and refined. Then
themes will be defined and labelled from the developed thematic map. The results will be reported with
the obtained themes (Braun & Clarke, 2006). |