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CTRI Number  CTRI/2025/05/087487 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Congnitive Behavioral therapy, Psychoeducational counselling and sound therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Audiologist-guided Internet-based cognitive behavioral therapy for Tinnitus 
Scientific Title of Study   Effectiveness of Audiologist-guided Internet-based cognitive behavioral therapy in Kannada for individuals with Tinnitus — A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Keerthana R 
Designation  PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9790941645  
Fax    
Email  keerthana2.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Hari Prakash P 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Hari Prakash P 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal


KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Keerthana R 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Prakash P  Kasturba Medical College and Kasturba Hospital  3rd floor, CTC building, Department of Speech and Hearing, Kasturba Hospital, Tiger Circle, Manipal
Udupi
KARNATAKA 		 9886135522

hari.prakash@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Audiologist-guided Internet-based Cognitive Behavioral Therapy  Its an 8-week online intervention program. It is self-paced, and an audiologist is available throughout the program to monitor and counsel as required. There are 22 modules of reading materials, videos, demonstrations, and surveys. The participants have to practice them at the recommended frequency and duration. These modules are based on cognitive behavioral therapy principles adapted for managing tinnitus. It includes mindfulness, positive imagery, sound enrichment, relaxation and breathing exercises, etc. After intervention of 8 weeks, to study the stability of the effects of intervention, a follow up after 2 months (16 weeks) is done to re-evaluate the outcomes. 
Comparator Agent  Psychoeducational counselling and sound therapy  Psychoeducational counseling for tinnitus will be provided as standard care, along with sound therapy and habituation strategies. They will practice these for a similar duration of 8 weeks and will be reviewed. Similarly, a post-intervention follow-up of 2 months (16 weeks) is done to study the effect of intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i) Individuals who are living in India
ii) Individuals with continuous and bothersome tinnitus for at least 3 months
iii) Mild or higher degree of tinnitus distress in Tinnitus Functional Index (TFI)
iv) Have completed schooling (12th standard)
v) Ability to read and comprehend Kannada
vi) Access to a computer and the Internet and the ability to browse and send e-mails 
 
ExclusionCriteria 
Details  i) Tinnitus associated with conductive, neurological causes and objective tinnitus
ii) Individuals under other interventions, including medical management for tinnitus
iii) Score of 15 and above on the Patient Health Questionnaire (PHQ-9) for depression and Generalized Anxiety Disorder (GAD-7) for anxiety, indicating a high need for direct psychological intervention.
iv) Individuals with a score of 25 or less in the Montreal Cognitive Assessment (MoCA) indicating the need for medical attention for mild cognitive impairment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Tinnitus severity -
i) Tinnitus Functional Index (TFI)
ii) Visual Analogue scale (VAS) 		 i) 3 Time points: Baseline, 8 weeks, 16 weeks
ii) 6 time points: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
i) Anxiety (Generalized Anxiety Disorder 7), Depression (Patient Health Questionnaire 9), sleep quality (Pittsburg Sleep Quality Index), Hearing & communication difficulty (Hearing Handicap Index), Overall quality of life (WHOQOL BREF)  i) 3 time points: baseline, 8 weeks, 16 weeks 
ii) Questionnaire for the impact of tinnitus on daily life  ii) 6 Time points: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks 
iii) Neuropsychological correlates - Spectral power changes & EEG connectivity measures  iii) 2 Time points - Baseline, 8 weeks 
iv) Satisfaction of program questionnaire  iv) 1 Time point: 8 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2/ Phase 3 
Date of First Enrollment (India)   11/06/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: Tinnitus is the sensation of hearing a sound without an actual sound present. It often causes distress and is associated with psychological conditions like anxiety, depression, sleep disturbance, lack of concentration, etc. Cognitive Behavioral Therapy (CBT) is a proven strategy that reduces tinnitus-related distress and improves the quality of life of individuals with tinnitus. It is also provided via the Internet (ICBT) as an Audiologist-guided intervention that is equally efficient and feasible in many countries worldwide.

In India, however, its treatment is restricted to non-standardized methods despite the prevalence being higher than the average. A review by Makar et al. (2012) found that CBT is one of the least utilized treatments for tinnitus in India. Evidence-based programs such as ICBT must be adapted and translated into Indian languages like Kannada to ensure their relevance and effectiveness. These behavioral therapies incorporate numerous real-life scenarios, beliefs, and examples specific to the culture and practices of the target population.

Therefore, ICBT must be validated for this specific group to accurately reflect their norms, values, and experiences. Its effectiveness should be clinically proven to establish it as a standard treatment protocol in India. Additionally, only self-reported measures have been used to study the effectiveness of ICBT on tinnitus; no objective EEG (Electroencephalography) based studies have been utilized. Studying the neurophysiological changes following ICBT in tinnitus will help understand the cortical dynamics following the intervention.

Hence the study aims to evaluate the effectiveness of Audiologists-guided Internet-based cognitive behavioral therapy in Kannada for individuals with tinnitus.

Primary Objectives:

• To adapt and validate the ICBT online intervention for the Kannada-speaking population.

• To assess the effectiveness of the tinnitus intervention program using self-reported and objective measures.

• To assess the satisfaction and usability of the intervention program.

Secondary Objectives

• To assess the stability of intervention effects 2 months after the intervention

The study will be done in 2 phases.

PHASE I: Translation and validation of ICBT in Kannada

The Indian English version of the ICBT intervention reading materials will first be translated and validated in Kannada. There are additionally 21 videos – 16 explaining the treatment procedures, 5 demonstrating the exercises, and one on awareness and introduction about the program. The recording will be done in a professional recording studio.

A unique web platform will be developed to host this program. This is a self-help program given with Audiologist support. It will be developed to be compatible with both interfaces – phones and computers.

Following this, the web program will be acceptability tested. This material is being developed as a part of an ICMR-approved study (3730-2020).

PHASE II: Effectiveness of ICBT in Kannada for individuals with tinnitus

There are two groups:

One group (Group 1) will receive the ICBT intervention. During the first visit, a baseline assessment of all the outcome measures (self-reported and EEG) will be done in person. They will follow the structured 8-week intervention and practice its contents at the recommended frequency. The participants will receive a unique user ID and password to log in and access the program. Investigators will have separate logins to view, monitor, and contact the participants. Biweekly reminders of the progress and a few measures (VAS and Questionnaire) will be assessed online. Post-intervention assessment (self-reported and EEG) will be done in person, and 2 months post-intervention, self-reported measures alone will be assessed.

The other group (Group 2) will receive standard care, which involves psychoeducational counseling and sound therapy. This will be provided in person during the first visit, along with baseline evaluations. They will be asked to practice these regularly and whenever required. Biweekly reviews on the progress and evaluations will be done online. Post-intervention evaluations will all be done similarly to Group 1.

If the individual is identified with hearing loss, they will receive standard treatment, which includes a hearing aid prescription. If they proceed to procure the aid, they will have a one-month habituation period, after which tinnitus and baseline outcome measures will be re-evaluated. Based on this, they will be recruited further for treatment allocation. If they don’t procure, they will be counseled on their hearing status and management strategies like communication strategies. Then, they will continue to be recruited for the study.

Audiological and tinnitus evaluations will be done for all participants.

Expected outcome:

An Internet-based Cognitive Behavioral Therapy (ICBT) program developed and validated for the management of tinnitus in India, which is feasible.

Insights into the neurophysiological mechanisms underlying the changes following CBT intervention for tinnitus and its association with subjective self-reported measures, providing an objective measure of the cortical changes following the intervention. 

This will help in establishing a standard treatment procedure for tinnitus intervention in India.

 
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