| CTRI Number |
CTRI/2022/01/039369 [Registered on: 12/01/2022] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occupational stress in persons with severe mental illness. |
|
Scientific Title of Study
|
Occupational stress in persons with severe mental illness |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHD ZAID |
| Designation |
MPhil Psychiatric Social Work Trainee |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Mental Health Institute, Sector-32, Chandigarh
PIN 160030
Mental Health Institute, Sector-32, Chandigarh
PIN 160032
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8439710201 |
| Fax |
|
| Email |
zaidshahkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MOHD ZAID |
| Designation |
MPhil Psychiatric Social Work Trainee |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Mental Health Institute, Sector-32, Chandigarh
PIN 160032
Mental Health Institute, Sector-32, Chandigarh
PIN 160032
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8439710201 |
| Fax |
|
| Email |
zaidshahkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHD ZAID |
| Designation |
MPhil Psychiatric Social Work Trainee |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Mental Health Institute, Sector-32, Chandigarh
PIN 160032
Mental Health Institute, Sector-32, Chandigarh
PIN 160032
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8439710201 |
| Fax |
|
| Email |
zaidshahkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government medical college and hospital |
| Address |
Mental Health Institute, Sector-32, Chandigarh
PIN 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Ajeet Sidana |
Government Medical College and Hospital, Chandigarh |
Department of Psychiatry, B Block 5th floor, GMCH, Sector-32, Chandigarh
Chandigarh
CHANDIGARH |
9646121614
ajeetsidana@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Above 18 years of age
Any gender
Diagnosis of SMI
Currently working for at least 3 months
Clinically stable patients |
|
| ExclusionCriteria |
| Details |
Unwillingness to participate in the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In this study, pre-assessment will be done by
using the following scales;
1. Socio-demographic Proforma
2. Clinical Data Sheet
3. General Health Questionnaire
4. Capacity Assessment Guidance document by Government of India
5. Job Stress Scale
6. WHOQOL-BREF Scale
7. Brief Coping Scale
The outcome will be focused on the occupational stress of severe mental illness patients. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The aim of this study is to assess and compare occupational stress and its correlates in persons with severe mental illness and healthy controls.
Job stress at the workplace of the participants by using Job stress scale.
Assess the quality of life by using WHOQOL-Bref.
Measure coping of the participants by using the Brief Coping scale. |
8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/01/2022 |
| 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="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be published after completion in any general which will be suitable for the researcher. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Employment is an important means of economic and social participation in adulthood; however, people with severe mental illnesses experience high unemployment rates (70–80%), lifelong disrupted work participation, and economic marginalization. Unemployment rates in persons with schizophrenia are as high as 80%. Unemployment increases mental health issues and employment also has a central role in social inclusion. Working individuals with severe mental illnesses like schizophrenia and bipolar disorders have difficulty in work due to their illness-related disadvantages. They often find it difficult to manage the demands at work and, at times, work demands provoke their illness. Work is arguably the single most significant parameter employed by the general public to measure recovery from illness. According to 2011 census data, the total number of persons suffering from mental illness in India was 722,826 (2.7 %). Central Statistics Organization reported that 87.3 % (873 out of 1,000) of persons with mental illness in India were out of the labor force. Not only the unemployment rate among severe mental illness but also creates a lot of barriers to continuing their job such as side effects of medication, stigma, poor social support, poor workplace environment, etc. which creates occupational stress among persons with severe mental illness. Thus, this study was planned to assess the occupational stress among persons with severe mental illness. |