Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome: Changes in tinnitus severity
研究概览
简要总结
clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.
Patients will be randomly divided into three groups:
- Group A: patients will receive Sound Therapy.
- Group B: patients will receive Cognitive Behavioral Therapy (CBT).
- Group C: patients will receive Combined CBT + Sound Therapy.
详细描述
Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.
Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .
In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Months 至 65 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Age: 18-65 years.
- •Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
- •Complaint: patients with chronic subjective tinnitus (> 3 months).
- •Psychological state: Patients with stable general and psychological condition.
排除标准
- •o Age: <18, >65 years
- •Hearing level: Patients with severe hearing loss not suitable for sound therapy
- •Complaint: Objective tinnitus (vascular or muscular origin)
- •Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- •Active middle or external ear disease
研究组 & 干预措施
Group A: patients will receive Sound Therapy
干预措施: Group A: sound therapy (Behavioral)
Group B: patients will receive Cognitive Behavioral Therapy (CBT).
干预措施: Group B: Cognitive Behavioral Therapy (Behavioral)
Group C: patients will receive Combined CBT + Sound Therapy.
干预措施: Group A: sound therapy (Behavioral)
Group C: patients will receive Combined CBT + Sound Therapy.
干预措施: Group B: Cognitive Behavioral Therapy (Behavioral)
Group C: patients will receive Combined CBT + Sound Therapy.
干预措施: Group C: Combined CBT + Sound Therapy (Behavioral)
结局指标
主要结局
Primary outcome: Changes in tinnitus severity
时间窗: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact
次要结局
- chang in Visual Analog Scale (VAS) score(Baseline, immediately after completion of treatment , and 3 months after completion of treatment)
- change in Tinnitus Handicap Inventory (THI) score(Baseline, immediately after completion of treatment , and 3 months after completion of treatment)
研究者
Aya Ahmed Elsayed
Resident at Audio-Vestibular unit ENT department at Sohag university hospital
Sohag University