1. Title of the project:  Efficacy of internet based Cognitive behavioural therapy (i-CBT) as the first line of treatment for chronic subjective tinnitus

2. Type of Study:   Prospective Observational study          

3. Aims & objectives :

•        Aim: To reduce the debilitating impact of chronic subjective tinnitus on a patient by internet based cognitive behavioural therapy.

•        Hypothesis:  A significant improvement in the patient’s perception of tinnitus will occur when the treatment comprises of the following:

1.      Comfort of their choice of place , with a minimum requirement of internet.

2.      Cost effective treatment modality

3.      Interactive and immersive modules

4.     Patients are self-assessing their progress with help from the clinician

5.     Long term benefits.

4. Justification for study (whether of national significance with rationale) :

•        Tinnitus is one of the most distressing hearing-related symptoms - defined as the conscious expression of a sound that originates in an involuntary manner in the ear or in the head. Subjective tinnitus is not heard by anyone else.

•        In this age and time we are not fully aware of the cause of tinnitus in many patients.

•        We should stop saying to the patient – nothing can be done for tinnitus and reinforce his/her negative perception of it.

•        We are unable to consistently quantify tinnitus as compared to other hearing related symptoms

•        Universally acceptable cost-effective drug/device/ surgical treatment does not exist .

5. Departments involved :

•        DEPT. OF OTO-RHINO-LARYNGOLOGY – Dr. Suresh Pillai, Dr. Poorvi Sharma, Dr. Tejaswi Tungapindi         

•        DEPT. OF SPEECH AND HEARING– Dr. Hari Prakash

•        DEPT. OF PSYCHIATRY – Dr. Samir Kumar Praharaj

6. Study period :

•        CASE INCLUSION :  After CTRI approval till  APRIL 2021.

•        FOLLOW UP: TILL AUGUST 2021

•        FOLLOW UP OF THE INTERVENTION WILL BE DONE AT 2 INTERVALS:

•        2 MONTHS (immediately after the completion of the 8-week intervention) and follow up at 4 MONTHS.

•        Patients will be reminded to come to the hospital via notifications for follow up to assess the efficacy of the intervention

7. Sample size :

•        Sample size: 38 (calculated using G Power software)

8. Materials and methods:   

            a) Inclusion and exclusion criteria:

INCLUSION CRITERIA:

1.     Aged above 18 years up till 75 years

2.     Literate and has access to an internet device with the ability to use the same with ease – either a smart phone or a computer.

3.     Commitment to complete the study and follow up upto 4 months.

4.     Understanding towards the end goal – tinnitus may remain the same or change, but the debilitating impact it has may come down

5.     Suffering from tinnitus for atleast 3 months – Subjective non pulstatile tinnitus.

6.     Pre-treatment scores of 26 and above on Tinnitus Functional Index  scale (TFI)

7.     Sensorineural hearing loss. 

     EXCLUSION CRITERIA

1.     Case of any medical or psychiatric condition.

2.     Any other cause of tinnitus – pulsatile, objective pending investigations.

3.     Tinnitus as a cause of any other undiagnosed medical condition.

            b) Biological materials required (type - blood, tissue etc and quantity): none

            c) Statistical methods: Analysis by repeated measures Anova

9. Detailed description of procedure / processes:

•        Written informed consent will be taken for each participant.

•        CT/MRI to rule out all other causes of tinnitus as a standard of care.

•        Assessment and establishing baseline disability due to tinnitus via Tinnitus Functional Index (TFI).

•        Assessment and establishing baseline depression via Hamilton Depression rating scale (HAM-D) and Inventory of Depressive Symptomology (IDS).

•        Assessment and establishing baseline hearing impairment via: Pure tone audiometry (PTA)/Tympanogram and matching the pitch and loudness of tinnitus.

•        The hospitals new webpage will used for this study. Each recruited participant of the study having the option of accessing the intervention modules added to his user profile.

•        All the clinicians will have individual logins to access the participants intervention profile and compliance can be noted by each department.

•        Using weekly intervention modules over 8 weeks in the form of questionnaires and work sheets and implementation of the same by the patient as weekly reading and daily practising. 

10. Outcome measures:

•        PRIMARY OUTCOMES

•        Change of score on Tinnitus Functional Index

•        Improvement in depression via Hamilton depression rating scale and Inventory of Depressive Symptomology.

•        SECONDARY OUTCOME

•        Improvement of hearing impairment by pitch and loudness matching on pure tone audiometry / tympanogram

11. Potential risks and benefits:

•        Risks:

•        There is no foreseeable risk to the patient upon participation in the study

•        Benefits

•        Decreasing the crippling effect of tinnitus on a patient and providing with a prolonged symptom free period.

12. Ethical considerations and methods to address issues:

•        Voluntary participation by the patient.

•        Informed consent.

•        No penalty for dropouts.

•        Anonymity of patients maintained – personal data of the patient will be stored as a part of the hospital records. Each patient will be given a number to create blinding.

13. Budget (give details) and proposed funding source: Nil