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

NCT07631403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Cognitive Behavioral Therapy (CBT)

Seven weekly group sessions of cognitive behavioral therapy, each lasting 90 minutes (5 to 7 participants per group), delivered by the same trained therapist. Sessions included psychoeducation, cognitive restructuring, attention control, and behavioral techniques targeting tinnitus-related distress.

OTHER

4-7-8 Breathing Exercise

The 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation.

OTHER

Psychoeducation

A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    collaborator OTHER_GOV

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-01-02
Completion
2026-05-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631403 on ClinicalTrials.gov