| 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
|
|
|
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
|
|
|
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. |