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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ankara、トルコ（Türkiye）
- Ankara Etlik City Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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アクティブコンパレータ：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.
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The 4-7-8 breathing technique practiced twice daily for 7 weeks following a standardized video protocol, intended to promote relaxation through parasympathetic activation.
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他の：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.
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A single psychoeducation session providing information about tinnitus to improve understanding and coping and to reduce uncertainty and anxiety.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tinnitus Handicap Inventory (THI)
時間枠：Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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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.
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Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Beck Anxiety Inventory (BAI)
時間枠：Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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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.
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Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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Beck Depression Inventory (BDI)
時間枠：Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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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.
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Baseline, post-intervention (week 7), 1-month follow-up, and 6-month follow-up
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2712
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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