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CBT, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress (TIN-CBP)

5. juni 2026 opdateret af: Gulce Kirazli, Ege University

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:

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Aktiv komparator: 4-7-8 Breathing Exercise
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.
Andet: 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.
Andet: Psychoeducation
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.
Andet: Psychoeducation
A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tinnitus Handicap Inventory (THI)
Tidsramme: 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.
Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Anxiety Inventory (BAI)
Tidsramme: 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.
Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
Beck Depression Inventory (BDI)
Tidsramme: 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.
Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ege University

Samarbejdspartnere

Ankara Etlik City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2025

Primær færdiggørelse (Faktiske)

2. januar 2026

Studieafslutning (Faktiske)

1. maj 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2712

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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Kliniske forsøg med Tinnitus

Kliniske forsøg med Cognitive Behavioral Therapy (CBT)

Søg i lignende forsøg

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