NCT00719940已完成4 期
Randomized Controlled Clinical Trial of Efficacy and Safety of Individual Cognitive Behavioral Therapy (CBT) Within the Setting of the Structured Therapy Program sTCP (Structured Tinnitus Care Program) in Patients With Tinnitus Aurium
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 7
- 主要终点
- Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
研究概览
简要总结
Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.
详细描述
Intervention:
Individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (TCP)"
Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks
Control intervention: Waiting group (16 weeks)
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
- None
入排标准
- 年龄范围
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent and stable tinnitus of more than 11 weeks
- •Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale
排除标准
- •Psychiatric or neurological comorbidity
- •Tinnitus as concomitant symptom of an otherwise treatable disease
- •Drug treatment for tinnitus 24 hrs. prior or during therapy
结局指标
主要结局
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
时间窗: Last session
次要结局
- Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale(last therapy session)
研究者
研究点 (7)
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