CompletedNot Applicable

CBT, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress

Turkey (Türkiye)70 participantsStarted 2025-06-01

Plain-language summary

Tinnitus is the perception of sound, such as ringing or buzzing, without any external source. It is common and can cause significant distress, including anxiety, depression, sleep problems, and reduced quality of life. Because there is currently no cure for tinnitus, treatment focuses on lowering the distress it causes and helping people cope. This study compared three different non-drug approaches to managing tinnitus-related distress: Cognitive behavioral therapy (CBT), a structured psychological treatment that helps people change unhelpful thoughts and reactions related to their tinnitus A breathing exercise (the 4-7-8 technique), a relaxation method intended to reduce stress Psychoeducation, which provides information to help people better understand their tinnitus Seventy adults with subjective tinnitus, aged 18 to 65, were randomly assigned to one of these three groups. Participants in each group received their assigned approach over a period of several weeks. The main goal was to see how much each approach reduced the impact of tinnitus on daily life, measured with a standard questionnaire called the Tinnitus Handicap Inventory. The study also looked at changes in anxiety and depression. Participants were assessed before treatment, after treatment, and again at 1 month and 6 months. The purpose of this study was to better understand which of these approaches may be most helpful for reducing tinnitus-related distress.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 65 years * Diagnosis of subjective tinnitus * Ability to read and complete questionnaires * Voluntary participation Exclusion Criteria: * Delirium, dementia, intellectual disability, or other organic mental disorders * Current psychiatric disorder according to DSM-5 criteria * History of alcohol or substance use disorder * Illiteracy * Abnormal otoscopic findings * History of otologic surgery * Otologic or vestibular disorders (e.g., otosclerosis, Meniere's disease) * Use of hearing aids * History of hearing loss * Respiratory diseases requiring ongoing treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tinnitus Handicap Inventory (THI)

Timeframe: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up

Trial details

NCT IDNCT07631403

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-02

View on ClinicalTrials.gov More Tinnitus trials