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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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