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临床试验/NCT02632058
NCT02632058Unknown不适用

Efficacy of Treatment for Tinnitus Based on Cognitive Behavioural Therapy in an Inpatient Setting: a 10-year Retrospective Outcome Analysis

Psychiatrische Dienste Graubuenden0 个研究点目标入组 500 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998).

研究概览

简要总结

Tinnitus is the acoustic perception of sound without any physical source. It is estimated that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation in all aspects of daily life of the affected.

There is currently no evidence for a successful treatment of tinnitus. While one treatment approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment aspect in our setting involved cognitive behavioural therapy.

详细描述

Tinnitus is the perception of sound in the ears or head unrelated to an external source [Nondahl 2011]. It is a common condition with a prevalence of 25.3% (approximately 50 million) among adults in the United States and increasing with age, peaking at age 60 - 69 years [Shargorodsky 2012] and above the age of 55 years respectively [Nondahl 2012]. Of individuals with tinnitus, 7.9% (approximately 16 million) experience frequent tinnitus which involves perception at least once daily [Shargorodsky 2012]. Prevalence of tinnitus in adults in Europe is described at a similar level with 21.2% [Hendrickx 2007]. In Switzerland prevalence for tinnitus in individuals over the age of 15 years is 20%; of these 13% report having a current tinnitus and 7% report of having had tinnitus in the past five years. [Bieri 2012]. It has been shown that the 10-year cumulative incidence for tinnitus is 12.7% [Nondahl 2010]. Gender seems to play a role in the predisposition for tinnitus; prevalence for men is 26.1% and for women 24.6% [Shargorodsky 2012], while the incidence for men is 14.8% and for women 11.2% [Nondahl 2010]. There is indication that there is also a gender-related level of affliction related to tinnitus, so that women feel more distress [Seydel 2013] and emotional disturbance than men [Pajor 2012].

It has also been shown for tinnitus to have a familial occurrence; subjects related to a sibling with tinnitus have a 1.7 times higher probability to have tinnitus than subjects from a family without tinnitus. [Hendrickx 2007]. Tinnitus perceived as severe has a prevalence of 1.3% [Nondahl 2012].

Risk factors for developing tinnitus are numerous and include conditions involving auditory function (i.e. hearing impairment, exposure to noise and history of ear surgery, head injury or otosclerosis), cardiovascular-related (i.e. cardiovascular disease, peripheral vascular disease, obesity, current smoking, higher number of packyears smoked and history of heavy alcohol consumption) [Nondahl 2012].

Tinnitus is also known to be associated with various complaints such as sleep disturbances, which are reported to be greater in elderly people [Hebert 2007], although there seems to be no difference between people suffering from insomnia with or without tinnitus, which was measured in a population of 38-62 year olds [Crönlein 2007]. Furthermore, tinnitus severity significantly correlates with depression and anxiety symptoms [Udupi 2013]. In addition, there is a higher incidence of somatoform disorders in individuals with tinnitus [Zirke 2013]. Although the severity of tinnitus is associated with anxiety and depression, a causality cannot be concluded [Zöger 2006].

Concerning treatment of tinnitus, tinnitus masking and tinnitus retraining therapy are two successfully applied methods. While both methods use counseling and acoustic stimulation for intervention, the main objective in tinnitus masking is to use wide-band noise applied through ear-level devices, in order to provide immediate relief from tinnitus [Henry 2006]. Although both methods show remarkable improvement in ameliorating tinnitus, in comparison the effects of tinnitus retraining therapy improve progressively over time [Henry 2006]. The results of tinnitus retraining therapy also sustain over time [Forti 2009] and improve quality of life of those affected [Seydel 2014].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • minimum age of 18,
  • existing Tinnitus auris or capitis

排除标准

  • Psychosis,
  • serious physical illness,
  • Organic psychiatric disability (ICD-10 F0x.x),
  • diseases classified under ICD-10 F2x.x,
  • Lack of capacity,
  • current substance abuse (F10.x - F19.x according to ICD-10, F17.x not included),
  • insufficient knowledge of German.

结局指标

主要结局

Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998).

时间窗: 6-8 weeks

次要结局

  • Brief Symptom Inventory (BSI, Derogatis 1975)(6-8 weeks)
  • Beck Depression Inventory (BDI, Beck 1961)(6-8 weeks)
  • Noise Sensitivity Questionnaire [Nelting 2004](6-8 weeks)

研究者

发起方
Psychiatrische Dienste Graubuenden
申办方类型
Other
责任方
Sponsor

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