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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).
 
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