Effect of Audiologist-guided Internet-based cognitive behavioral therapy for Tinnitus

Phase 2/3

Not yet recruiting

Conditions: Diseases of the ear and mastoid process,

Registration Number: CTRI/2025/05/087487

Lead Sponsor: Keerthana R

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i) Tinnitus Functional Index (TFI)	i) 3 Time points: Baseline, 8 weeks, 16 weeks \| ii) 6 time points: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks
Tinnitus severity -	i) 3 Time points: Baseline, 8 weeks, 16 weeks \| ii) 6 time points: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks
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 Measures

Name	Time	Method
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
iv) Satisfaction of program questionnaire	iv) 1 Time point: 8 weeks
iii) Neuropsychological correlates - Spectral power changes & EEG connectivity measures	iii) 2 Time points - Baseline, 8 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

Trial Locations

Locations (1): Kasturba Medical College and Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College and Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Hari Prakash P
Principal investigator
9886135522
hari.prakash@manipal.edu