| CTRI Number |
CTRI/2018/03/012568 [Registered on: 15/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validity of the Marathi version of the Hospital and Anxiety Depression Scale in cancer patients |
|
Scientific Title of Study
|
Reliability and validity of the Marathi version of the Hospital and Anxiety Depression Scale in adjustment, anxiety and depressive disorders in cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Psychiatric Unit, Golden Jubilee Block, Basement, Room no 20, Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Psychiatric Unit, Golden Jubilee Block, Basement, Room no 20, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Psychiatric Uit, Golden Jubilee Block, Basement, Room no 20, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Self, Psychiatric Unit, Golden Jubilee Block, Basement, Room no 20, Tata Memorial Hospital, Dr. E. Borges Road, Parel,
|
|
|
Primary Sponsor
|
| Name |
Savita Goswami |
| Address |
Tata Memorial Hospital
Ernest Borges Marg,
Parel,Mumbai- 400012 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Savita Goswami |
Tata Memorial Hospital |
Psychiatric Unit, Golden Jubilee Block, Basement, Room no 20, Tata Memorial Hospital, Dr. E. Borges Road, Parel,
Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA |
9820050072
022-24146937
savitata@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
50 Adult cancer patients and 50 caregivers of cancer patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Marathi speaking
2. Able to undergo psychiatric clinical interview
3. Able to give informed consent |
|
| ExclusionCriteria |
| Details |
1. History of pre-existing psychiatric illness including psychotic disorder
2. Cognitive impairment
3. Delirium or dementia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary -
Internal consistency by Cronbach’s alpha,
Sensitivity, specificity, ROC
|
single time point at enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary -
Factor structure (by PCA)
|
single time point at enrollment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2013 |
| Date of Study Completion (India) |
16/06/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to examine reliability and validity of Marathi version of Hospital Anxiety Depression Scale in screening for adjustment disorder, anxiety and depression in cancer patients. The objectives are to determine 1. Internal consistency 2. Factor structure 3. Sensitivity and specificity by receiver Operating Characteristics analysis and optimum cutoff points for each of the diagnosis, using psychiatric interview for diagnosing adjustment disorder, anxiety disorder and depressive episode/disorder according to ICD-10 as gold standard.
We hypothesize that the Marathi translation of the HADS will demonstrate adequate internal consistency and a two factor structure, satisfactory sensitivity and specificity and optimal cut off points for sub scale and total score similar to other studies in the literature. |