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

NCT07631403 | Completed DMC

• 1 other identifier: 2712
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Tinnitus

Keywords

tinnitus; Cognitive Behavioral Therapy; Randomized Controlled Trial; Breathing Exercises; Psychoeducation

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  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.

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

Secondary Outcomes (2)

• Beck Anxiety Inventory (BAI)

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

• Beck Depression Inventory (BDI)

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

Study Arms (3)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Participants attended seven weekly group sessions of cognitive behavioral therapy, each lasting 90 minutes, with 5 to 7 participants per group. Sessions included psychoeducation, cognitive restructuring, attention control, and behavioral techniques aimed at reducing tinnitus-related distress. All sessions were led by the same trained therapist to ensure consistency.

Other: Cognitive Behavioral Therapy (CBT)

4-7-8 Breathing Exercise

ACTIVE COMPARATOR

Participants practiced the 4-7-8 breathing technique twice daily for 7 weeks, following a standardized video protocol. This relaxation-based technique is intended to activate the parasympathetic nervous system and promote relaxation to reduce tinnitus-related distress.

Other: 4-7-8 Breathing Exercise

Psychoeducation

OTHER

Participants received a single psychoeducation session providing information about tinnitus to improve understanding and coping, and to reduce uncertainty and anxiety. This arm served as the comparison condition.

Other: Psychoeducation

Interventions

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.

4-7-8 Breathing Exercise

Psychoeducation OTHER

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

Psychoeducation

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.

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Diagnosis of subjective tinnitus
• Ability to read and complete questionnaires
• Voluntary participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• Ankara Etlik City Hospital: collaborator

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2025
• Primary Completion: January 2, 2026
• Study Completion: May 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)