FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048451 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Solution-Focused Brief Intervention to improve mental health, satisfaction with life and reduce burden of caregivers of schizophrenic patients. 
Scientific Title of Study   Solution-Focused Brief Intervention for Caregivers of Persons Living with Schizophrenia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit Kumar 
Designation  PhD in Psychiatric Social Work 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Psychiatric social work, NIMHANS, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9113432517  
Fax    
Email  amit123.ak69@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Janaki Raman 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Room no 110 MVG building Department of Psychiatric Social Work NIMHANS Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  8903511045  
Fax    
Email  janakitrichy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amit Kumar 
Designation  PhD in Psychiatric Social Work 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Psychiatric Social work, NIMHANS, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9113432517  
Fax    
Email  amit123.ak69@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002. 
 
Primary Sponsor  
Name  Not Appliacble 
Address  Not Applicable 
Type of Sponsor  Other [Not Applicable] 
 
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 
Amit Kumar  NIMHANS  Room no. 110 Department of psychiatric social work, NIMHANS
Bangalore
KARNATAKA 		 9113432517

amit123.ak69@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  Approved 
NIMHANS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of Persons Living with Schizophrenia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Psychoeducation  2 sessions of psychoeducation would be given to Control Group. 
Intervention  Solution-Focused Brief Intervention  Focused group discussion(FGD) with the experts and in-depth case studies with the caregivers of schizophrenia will be done. Intervention will be developed after the findings from FGD group and case study group. 3 to 4 sessions of FGD would be conducted with the experts and in-depth case study will have 1 session with the every caregivers. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Caregivers of Schizophrenia
2. Age Range: 18 to 60 years
3. Duration of illness: 3 years and above
4. Person who can speak Hindi and English
5. The primary caregivers who are directly involved and stay with the patient can be anyone Eg: Parents, Siblings, or Extended family members.
 
 
ExclusionCriteria 
Details  1. Caregivers who are having a severe psychiatric disorder
2. Caregivers with intellectual disabilities.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Caregiver burden, Coping, Quality of life  The measures will be repeated after completing the sessions and follow-up after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived social support, Personality  baseline 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   31/01/2023 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amit123.ak69@gmail.com].

  6. For how long will this data be available start date provided 27-01-2023 and end date provided 31-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Not Applicable
Brief Summary   The study has got clearance from the Institute Ethics Committee, but data collection is yet to be started. 
Close