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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Comparateur actif: 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.
Autre: 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.
Autre: 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.
Autre: Psychoeducation
A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Tinnitus Handicap Inventory (THI)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Beck Anxiety Inventory (BAI)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ege University

Collaborateurs

Ankara Etlik City Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 janvier 2026

Achèvement primaire (Réel)

2 juin 2026

Achèvement de l'étude (Réel)

15 juin 2026

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

5 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2712

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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