TinnitusTIN-CBPNCT07631403
CBT, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress
A study testing Cognitive Behavioral Therapy (CBT), 4-7-8 Breathing Exercise and Psychoeducation in people with Tinnitus, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cognitive Behavioral Therapy (CBT), 4-7-8 Breathing Exercise and Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of subjective tinnitus
- Ability to read and complete questionnaires
- Voluntary participation
Who cannot join
- 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
Show all 10Show fewer
- Otologic or vestibular disorders (e.g., otosclerosis, Meniere's disease)
- Use of hearing aids
- History of hearing loss
- Respiratory diseases requiring ongoing treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Cognitive Behavioral Therapy, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress: A Randomized Controlled Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Tinnitus
- Being tested
- Cognitive Behavioral Therapy (CBT), 4-7-8 Breathing Exercise, Psychoeducation
- Keywords
- tinnitus, Cognitive Behavioral Therapy, Randomized Controlled Trial, Breathing Exercises, Psychoeducation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ExerciseOther
The 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation.
PsychoeducationOther
A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start5 Jan 2026
- Primary completion2 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Principal investigator, Gulce Kirazli, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631403
- Sponsor's protocol ID
- 2712
- Acronym
- TIN-CBP
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Cognitive Behavioral Therapy, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07631403
- Acronym / sponsor ID
- TIN-CBP / 2712
- Conditions
- Tinnitus
- Keywords
- tinnitus, Cognitive Behavioral Therapy, Randomized Controlled Trial, Breathing Exercises, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Other: Cognitive Behavioral Therapy (CBT)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. |
| 4-7-8 Breathing Exercise | Active comparator | Other: 4-7-8 Breathing ExerciseParticipants 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. |
| Psychoeducation | Other | Other: PsychoeducationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Diagnosis of subjective tinnitus
- Ability to read and complete questionnaires
- Voluntary participation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cognitive Behavioral Therapy (CBT) |
| 4-7-8 Breathing ExerciseThe 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation. | Other | 4-7-8 Breathing Exercise |
| PsychoeducationA single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety. | Other | Psychoeducation |
Primary outcome
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.
2 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Beck Depression Inventory (BDI)
Time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), 4-7-8 Breathing Exercise and Psychoeducation in people with Tinnitus, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.