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Completed

NCT Number: NCT07631403

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

Tinnitus is a heterogeneous condition with multifactorial pathophysiology involving both auditory and non-auditory networks. Because no curative treatment exists, management focuses on reducing tinnitus-related distress and improving quality of life. Psychological and behavioral interventions have shown promise, but direct comparisons between approaches are limited.

This exploratory randomized controlled study compared three non-pharmacological interventions: cognitive behavioral therapy, the 4-7-8 breathing technique, and psychoeducation. Participants were assigned in a 1:1:1 ratio using a computer-generated randomization sequence. The sequence was generated before enrollment, and group assignment was withheld until after baseline assessments were completed.

The investigators hypothesized that cognitive behavioral therapy would produce the greatest improvement in tinnitus-related outcomes, followed by the 4-7-8 breathing technique, with psychoeducation producing the least improvement. Intervention intensity differed across groups, and this contact-time imbalance was considered when interpreting the findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy (CBT)

Other

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.

4-7-8 Breathing Exercise

Other

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

Psychoeducation

Other

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

Primary outcomes

  1. Tinnitus Handicap Inventory (THI)

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

    The Tinnitus Handicap Inventory is a validated 25-item self-report questionnaire assessing the impact of tinnitus on daily functioning. Total scores range from 0 to 100, with higher scores indicating greater tinnitus-related handicap.

Secondary outcomes

  1. Beck Anxiety Inventory (BAI)

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

    The Beck Anxiety Inventory is a validated 21-item self-report scale measuring the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety.

  2. Beck Depression Inventory (BDI)

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

    The Beck Depression Inventory is a validated 21-item self-report scale measuring the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater depression.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Ankara Etlik City Hospital

Registry information

Official study title

Comparative Effects of Cognitive Behavioral Therapy, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress: A Randomized Controlled Study

Acronym: TIN-CBP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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