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CTRI Number  CTRI/2023/09/057717 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 05/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Life skills profile and social functioning among patients with schizophrenia. 
Scientific Title of Study   Life skills profile and social functioning among patients with schizophrenia visiting tertiary mental healthcare institution, Assam. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nivamani Barman 
Designation  M.Sc. Nusing trainee 
Affiliation  LGBRIMH 
Address  Dept. of Psychiatric Nursing, LGBRIMH, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  8811096195  
Fax    
Email  nivamanibarman14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nurnahar Ahmed 
Designation  Associate professor 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Dept. of Psychiatric Nursing, 3rd floor Academic building, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur
Do
Sonitpur
ASSAM
784001
India 
Phone  9854341201  
Fax    
Email  anurnahar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nivamani Barman 
Designation  M.Sc. Nusing trainee 
Affiliation  LGBRIMH 
Address  Dept. of Psychiatric Nursing, LGBRIMH, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  8811096195  
Fax    
Email  nivamanibarman14@gmail.com  
 
Source of Monetary or Material Support  
Principal investigator, Institution: Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam 
 
Primary Sponsor  
Name  Nivamani Barman 
Address  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam 
Type of Sponsor  Other [Self funded] 
 
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 
Nivamani Barman  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam  Adult OPD, Department of Adult Psychiatry, Ground floor, Room no: 03
Sonitpur
ASSAM 
8811096195

nivamanibarman14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, LGBRIMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F200||Paranoid schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patients diagnosed with schizophrenia by treating team as per ICD- 10 criteria between the age group of 18-60 years.

The patients who can give consent for the study. 
 
ExclusionCriteria 
Details  The patients diagnosed with schizophrenia co morbid with other mental illness.

The patients who are unable to give consent for the study 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
New knowledge can be generated from the study which enrich the field of science  New knowledge can be generated from the study which enrich the field of science 
 
Secondary Outcome  
Outcome  TimePoints 
The study results help in formulating new intervention or modify exiting intervention.  It can shape the future intervention. 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
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)   20/09/2023 
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="1"
Months="0"
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  

Schizophrenia remains one of the major psychiatric disorders with huge social and economic costs for the individual and community. Lack of social functioning and inadequate life skills have impact on everyday life of people with this diagnosis. Studies showed that deficits in social functioning are one of the main drivers of the global burden of the disorder. According to the report given by WHO at the year 2022 approximately 24 million people were affected by schizophrenia worldwide. Is it well recognized that deficits in social functioning expressed through poor social interactions and difficulties in building and maintaining familial or friendly relationships are a core feature of schizophrenia. Therefore studies to be done to determine the life skills profile and social functioning of this group so that newer intervention can be added to improve the quality of life of these patients. The aim of the study is to determine the life skills profile and social functioning among the patients with schizophrenia visiting tertiary mental healthcare institution, Assam. Methodology of present study- the research approach will be quantitative in nature, design will be descriptive design, and setting of the study will be tertiary mental healthcare institute, Assam. Study sample includes 103 patients with schizophrenia visiting tertiary mental healthcare institution who will be selected by using convenient sampling. Data will be collected by self structured Socio- demographic proforma, LIFE SKILLS PROFILE -20 and SOCIAL FUNCTIONING SCALE after translating to local language.  After collecting data it will be analyzed by descriptive and inferential statistics. 


 
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