| CTRI Number |
CTRI/2020/10/028701 [Registered on: 28/10/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
online treatment for tinnitus in Tamil, Kannada and Hindi |
|
Scientific Title of Study
|
Translation and Validation of internet based Cognitive Behavioural Therapy (iCBT) for Tinnitus in Tamil, Kannada and Hindi |
| Trial Acronym |
CBTIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Prakash Palaniswamy |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of HIgher Education (MAHE) |
| Address |
Dept. of Speech and Hearing,
Manipal College of Health Professions (MCHP), MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hari Prakash Palaniswamy |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of HIgher Education (MAHE) |
| Address |
Dept. of Speech and Hearing,
Manipal College of Health Professions (MCHP), MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Hari Prakash Palaniswamy |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of HIgher Education (MAHE) |
| Address |
Dept. of Speech and Hearing,
Manipal College of Health Professions (MCHP), MAHE, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE), Ground Floor, University Building, Tiger Circle, MAnipal 576104 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Prakash Palaniswamy |
Manipal Academy of Higher Education (MAHE) |
3rd Floor, CTC Building, Dept. of speech and Hearing, Kasturba Hospital, Tiger circle, Manipal Udupi KARNATAKA |
9886135522
hari.prakash@manipal.edu |
| Meenakshi Wadhera |
Meenakshi Speech and Hearing Clinics Pvt Ltd |
Professors Colony, Civil Lines, Agra, Uttar Pradesh 282002 Agra UTTAR PRADESH |
9810045247
meenakshiwadhera@gmail.com |
| Dr Heramba Ganapathy |
Sri Ramachandra Institute of Higher Education and Research (SRIHER) |
Dept. of Speech and Hearing, SRIHER, Porur, Chennai Chennai TAMIL NADU |
9566261941
hega@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Meenakshi speech and hearing clinic letter of undertaking |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals with no tinnitus and proficient in Tamil/ Kannada or Hindi language |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioural Therapy (CBT) for tinnitus |
AN 8 week treatment hosted online which guided by an audiologist.
Participants will have to go through 22 modulules (8 optional) wherein videos and information regarding how to change their view on tinnitus and create a positive imagery is provided. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are above 18 years of age and living in India
Individuals with bothersome and continuous tinnitus for about 3 months and at least mild degree of handicap (as indexed using Tinnitus Handicap Inventory, THI)
Access to a computer and the Internet and the ability to browse the Internet and send e-mail
Ability to read and comprehend English/ Tamil/ Kannada or Hindi.
Motivated and interested to participate in the treatment programme
|
|
| ExclusionCriteria |
| Details |
Individuals with any major medical, psychological, or neurological conditions which will hamper their ability to undertake the intervention will be excluded
When the cause of tinnitus is still under medical investigation, individuals may be excluded if further medical treatment is indicated (such as surgical procedures)
Individuals who are currently undergoing treatment for tinnitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
three scales are being used to measure the outcome along with a semi-structured interview on the participants experience of treatment
Tinnitus Handicap Index (THI) Scores
Participant Health Questionnaire (PHQ-9)
Subjective rating of tinnitus (VAS)
|
0 weeks and 8 weeks and 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| distress and annoyance caused by tinnitus using a Visual Analogue Scale (VAS) |
three time points
0 weeks pre treatment
8 weeks post treatment
1 month post treatment follow up |
|
|
Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2021 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief introduction: Individuals with continuous tinnitus often experience distress, anxiety, depression, irritability, poor concentration, and lifestyle changes due to the lack of silence in their life. Cognitive Behavioral Therapy (CBT) is proven to be effective in reducing tinnitus and it’s related distress. In order to increase the accessibility and reach, CBT was provided via the internet guided either by a psychologist or an audiologist. This internet-based treatment delivery of CBT is referred to as iCBT. Research in European countries like Sweden, the United Kingdom, and Germany have indicated its potential effectiveness. There is a dearth of such tinnitus treatment programme in India, where non-standardized and non-evidence based treatment maneuver is in practice. Adaptation of such protocols in India seems to be a virtuous start towards standard and evidence-based treatment for individuals with tinnitus. The current version of iCBT running consist of an 8-week treatment that is hosted online with interactions to an audiologist. The current study enfolds three phases, aiming to translate the Indian English version of CBT into three Indian Languages (Tamil, Kannada and Hindi) followed by, converting this material into an electronic module with the usage of videos and web-based platform to deliver this treatment. Subsequently the developed iCBT module will undergo a field test to check its feasibility and the satisfaction of the participants with tinnitus who underwent the treatment. The proposed project systematically assesses the acceptability, feasibility and efficacy of iCBT in Indian population. Study Objectives 1. To translate and adapt CBT for tinnitus into Tamil, Kannada and Hindi Language to be suitable for Indian population and validate the CBT targeting tinnitus treatment. 2. To develop an internet module for the delivery of CBT (iCBT) 3. To assess the acceptability of the intervention amongst service users and professionals and determine the feasibility of iCBT in Indian Scenario. The study includes 3 phases. Phase 1 mainly involves in the translation of treatment material (22 modules) in three Indian Languages with the help of professional translators and then checking the familiarity of words used along with the comprehensibility of the modules by both individuals with tinnitus and non-medical professionals. Finally content validation of the material with the help of subject experts. Phase 2 involves development of videos that aid in understanding of the modules better and create an internet based platform to host the treatment with the help of our technical team Phase 3 involves checking the feasibility of the treatment with the help of individuals with tinnitus. Participants can log in through their phone or laptop and undergo the 8 week treatment for tinnitus. A pre and post evaluation will be carried out to check for any improvement and a semi-structured interview will be conducted to obtain the participants opinion on the treatment and further modification.
The current study is to translate and validate an internet based treatment for tinnitus and check its feasibility in India. |