CBT, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress (TIN-CBP)
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Ankara, Турция (Туркие)
- Ankara Etlik City Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
|
|
Активный компаратор: 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.
|
The 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation.
|
|
Другой: 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.
|
A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Tinnitus Handicap Inventory (THI)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания нервной системы
- Оториноларингологические заболевания
- Расстройства чувствительности
- Ушные заболевания
- Нарушения слуха
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Шум в ушах
- Поведенческая терапия
- Психотерапия
- Поведенческие дисциплины и деятельность
- Когнитивная поведенческая терапия
Другие идентификационные номера исследования
- 2712
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .