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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Ankara、土耳其（türkiye）
- Ankara Etlik City Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
有源比较器：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.
|
|
其他：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tinnitus Handicap Inventory (THI)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Beck Anxiety Inventory (BAI)
大体时间：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)
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2712
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.