| CTRI Number |
CTRI/2024/08/072763 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Scale Translation Study] |
| Study Design |
Other |
|
Public Title of Study
|
Translation , Reliability and Validity of Beck Depression Inventory-II in Gujarati version in people with acute stroke |
|
Scientific Title of Study
|
Cross- Cultural Adaptation, Reliability and validity of Gujarati Version of the Beck Depression Inventory- II in people with acute stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishvi Patel |
| Designation |
MPT Scholar |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara GUJARAT 391760 India |
| Phone |
6351385868 |
| Fax |
|
| Email |
aishvi56@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrChaitali Shah |
| Designation |
Associate professor |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9998107262 |
| Fax |
|
| Email |
chaitalishah@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
DrChaitali Shah |
| Designation |
Associate professor |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
GUJARAT 391760 India |
| Phone |
9998107262 |
| Fax |
|
| Email |
chaitalishah@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| room no. 309 3rd floor Parul Institute of Physiotherapy, parul university post. Limda waghodia vadodara gujarat Vadodara
GUJARAT
391760 India |
|
|
Primary Sponsor
|
| Name |
Aishvi Patel |
| Address |
room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat, India
pincode 391760 |
| 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 |
| DrAishvi Patel |
Parul Sevashram Hospital |
room no. 232 neuro opd, 2nd floor, parul sevashram hospital , parul university, post limda, waghodia, gujarat, India
Vadodara GUJARAT |
6351385868
aishvi56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul university institutional ethics committee for human research |
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
|
| Type |
Name |
Details |
| Intervention |
Beck Depression Inventory-II |
The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions
for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13.Over the course of a month, it poses questions regarding low mood, feelings The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions
for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13.Over the course of a month, it poses questions regarding low mood, feelings of helplessness, psychomotor retardation, guilt and restlessness, and depression. (7) There have been two significant updates to the BDI: the BDI-I in 1978 and the BDI-II in 1996. The improved BDI-II measures physical and psychological symptoms of major depression episodes lasting two weeks. |
| Comparator Agent |
Reliability and Validity of the Gujarati Version of the Beck Depression Inventory-II |
Beck Depression Inventory-II will be translated into Gujarati Version and then Reliability and Validity of the scale will be calculated |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are ready to give consent. Participants diagnosed with ischemic or hemorrhagic stroke by physician or neurophysician.
Both male and females.
Able to understand Gujarati language.
Able to follow commands. |
|
| ExclusionCriteria |
| Details |
Any cognitive or perceptual disorders.
Any visuospatial impairment
Patient severe consciousness problem
Has referred psychiatrist and undergoing treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beck Depression Inventory-II |
1 day/week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geriatric Depression scale-15 |
1 day/ week |
|
|
Target Sample Size
|
Total Sample Size="210" Sample Size from India="210"
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)
|
05/09/2024 |
| 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="0" Months="6" 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
|
Depression is one of the most common neuropsychiatric disorders in stroke patients. Post stroke depression (PSD) is a well-known phenomenon and It occurs in at least a quarter of stroke survivors in the first year after the stroke. About one in three stroke survivors suffered from depression after the stroke. Post stroke depression nearly affects 85% of the strokes and is linked to more severe functional dysfunction, poor rehabilitation outcomes, and social isolation after stroke Depressed mood apathy, weight loss or increase, sleep disturbances, exhaustion, worthlessness, and anhedonia are the primary clinical signs of post stroke depression. This greatly affected functional rehabilitation, causing a poor quality of life. The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13. Over the course of a month, it poses questions regarding low mood, feelings of helplessness, psychomotor retardation, guilt and restlessness, and depression.There have been two significant updates to the BDI: the BDI-I in 1978 and the BDI-II in 1996. The improved BDI-II measures physical and psychological symptoms of major depression episodes lasting two weeks. Some components have been replaced in this version. Agitation, worthlessness, difficulty concentrating, and energy loss were substituted for four BDI-I items that proved less sensitive for identifying typical symptoms of severe depression: weight loss, distorted body image, somatic preoccupation, and inability to work.The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. In those diagnosed with depression, scores of 0–13 indicate minimal depression, 14–19 (mild depression), 20–28 (moderate depression) and 29–63 (severe depression) The scores above 20 indicate depression. |