An interventional study of Cognitive Behavioral Therapy (CBT) and 4-7-8 Breathing Exercise in Tinnitus, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
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.
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.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
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
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.
The 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation.
A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.
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.
Time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Beck Anxiety Inventory (BAI)
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.
Time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Beck Depression Inventory (BDI)
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.
Time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional ethics committee approval.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ege University