| CTRI Number |
CTRI/2022/03/040767 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess self-esteem and psychosocial stress among the persons with substance use disorder. |
|
Scientific Title of Study
|
A study to assess Self- Esteem and Psychosocial Stress among the Persons with Substance Use Disorder Attending a Tertiary Mental Health Care Setting. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Thangjam |
| Designation |
M.Sc. Psychiatric Nursing 1st Year |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health. |
| Address |
Department of Psychiatric Nursing.
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health.Tezpur.
Sonitpur
ASSAM
784001
India |
| Phone |
8787494746 |
| Fax |
|
| Email |
sushmathangjam62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nurnahar Ahmed |
| Designation |
Assistant professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health. |
| Address |
Department of Psychiatric Nursing.
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health.Tezpur.
Sonitpur
ASSAM
784001
India |
| Phone |
9365423096 |
| Fax |
|
| Email |
anurnahar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushma Thangjam |
| Designation |
M.Sc. Psychiatric Nursing 1st Year |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health. |
| Address |
Department of Psychiatric Nursing.
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health.Tezpur.
Sonitpur
ASSAM
784001
India |
| Phone |
8787494746 |
| Fax |
|
| Email |
sushmathangjam62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokopriya Gopinath Bordoloi Regional institute of mental health. Tezpur Assam |
|
|
Primary Sponsor
|
| Name |
Sushma Thangjam |
| Address |
Department of Psychiatric Nursing, 3rd Floor
Lokopriya Gopinath Bordoloi Regional Institute of Mental health,Tezpur |
| 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 |
| Dr Nurnahar Ahmed |
LGBRIMH Tezpur |
LGBRIMH,Tezpur Assam out patient department Room NO.23, DAM block and Inpatient Unit NO. I,II,III.
Sonitpur
ASSAM |
9365423096
anurnahar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Person diagnosed as substance use disorder who attend LGBRIMH, Tezpur.
2. Person who can read and understand either English and Assamese. |
|
| ExclusionCriteria |
| Details |
1. Person with active psychopathology
2. Person with substance use disorder presently on delirium state.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcome of the study would be a correlational effects between self-esteem and psychological stress among the persons with substance use disorder. |
39 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The expected outcome result of the study would be positive association between self esteem and psychosocial stress among the persons with substance use disorder. |
78 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
02/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will adopt a descriptive research design
with quantitative research approach. The study will be conducted in a tertiary
mental health care setting. Total 60 number of persons diagnosed with substance
use disorder attending tertiary mental healthcare setting during data
collection periods will be the sample of the study. Person who can read and
understand either assamese or english will be selected through purposive
sampling technique. The socio demographic and clinical variables datasheet,
Rosenberg self-esteem scale (10items) and perceived stress scale (10items) will
be used to collect the data. The informed consent will be taken from
participants after proper explanation and assurance for confidentiality and
anonymity of data. The study does not include any invasive procedures. The
collected data will be analysis with appropriate descriptive statistics
(central tendency, standard deviation) and Inferential statistics- (Chi- square
test and karl-pearson correlation coefficient. |