| CTRI Number |
CTRI/2024/05/067747 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the Personal Recovery Among Employed and Unemployed Persons with Bipolar Affective Disorder |
|
Scientific Title of Study
|
Personal Recovery and Its Psychosocial Correlates Among Employed and Unemployed Persons with Bipolar Affective Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrinal Basumatary |
| Designation |
PhD Scholar |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam |
| Address |
Department of Psychiatric Social Work, Academic Building, LGB Regional Institute of Mental Health, Tezpur, Assam, India
Kalibari Main Road, Mahabhairab, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9957469428 |
| Fax |
|
| Email |
mrinalbasu99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrajeet Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam |
| Address |
Department of Psychiatric Social Work, Academic Building, LGB Regional Institute of Mental Health, Tezpur, Assam, India
Kalibari Main Road, Mahabhairab, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9435704216 |
| Fax |
|
| Email |
indraj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrinal Basumatary |
| Designation |
PhD Scholar |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam |
| Address |
Department of Psychiatric Social Work, Academic Building, LGB Regional Institute of Mental Health , Tezpur, Assam, India
Kalibari Main Road, Mahabhairab, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9957469428 |
| Fax |
|
| Email |
mrinalbasu99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, 784001, Assam, India |
|
|
Primary Sponsor
|
| Name |
Mrinal Basumatary |
| Address |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, 784001, Assam, India |
| 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 |
| Mrinal Basumatary |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur |
OPD Room No: 26, Department of Psychiatric Social Work
Sonitpur
ASSAM |
9957469428
mrinalbasu99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LGB Regional Institute of Mental Health, Tezpur, Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F31||Bipolar disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with Bipolar Affective Disorder as per ICD-10 criteria for Mood (Affective) Disorders. Both gender. Aged 20-59 years. The duration of illness more than 1 year and taking treatment from LGBRIMH. Participant currently in euthymic state. Those who are able to understand Assamese or English will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Participants with co-morbid psychiatric disorders and serious physical illness, substance dependence except Nicotine will be excluded
2. Participants having intellectual or any other disabilities will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The researcher will be able to know more about the Personal recovery and its psychosocial correlates among persons with Bipolar Affective Disorder who are employed and unemployed |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/06/2024 |
| 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 Yet Recruiting |
| 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
|
Mental Health Recovery is based on evidence that people with severe mental illness can live autonomous, contributing and satisfying lives in the community even in the presence of persisting symptoms. personal recovery is understood as a way of living a satisfying, hopeful and contributing life even with limitations caused by illness. Studies have shown that individuals diagnosed with psychiatric illness can lead a productive and fulfilling life and their recovery can be facilitated when clinicians broaden their focus to understand the difficulties faced by them in dealing with their illness. Therefor the present study aims to assess the personal recovery and its psychosocial correlates among employed and unemployed persons with Bipolar Affective Disorder. The objective of the study are to assess the socio-demographic, clinical profile, personal recovery among employed and unemployed, to investigate the relationship between personal recovery with selected socio-demographic and clinical variables among employed and unemployed persons, to determine the correlation of personal recovery and its psychosocial correlates and to examine the socio-demographic, clinical and psychosocial predictors of personal recovery among employed and unemployed persons with Bipolar Affective Disorder. |