Efficacy of an Internet-based Guided Self-help Training for Chronic Tinnitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
研究概览
简要总结
The purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a German sample.
详细描述
Long waiting periods and the deficiency of outpatient therapies stimulated the development of internet-based interventions for a variety of mental disorders during the last years. A Swedish research group developed an internet-based self-help training for patients with chronic tinnitus showing promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). This self-help training was now adapted for German-speaking patients. The present study evaluates the efficacy of this treatment in a randomized controlled trial conducted in Germany. Further aims are a process evaluation of the treatment and the identification of predictors of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 18 years
- •Chronic tinnitus for at least 6 months
- •Medical examination of tinnitus by an ear, nose and throat physician (ENT)
- •Scoring 38 or above on the Tinnitus Handicap Inventory (THI) or scoring 13 or above on the Mini-Tinnitus Questionnaire (Mini-TQ)
- •Not currently receiving psychological treatment for tinnitus
- •Being able to access the Internet and print instructions
- •Sufficient knowledge of the German language to read and follow the Internet-based self-help program
排除标准
- •Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
- •Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
- •Clinical diagnosis of Dementia or another severe organic cerebral disorder
- •Clinical diagnosis of substance-related addiction/abuse
结局指标
主要结局
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
时间窗: 18 months
The measure assesses tinnitus-related disability and handicap.
MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)
时间窗: 18 months
The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel \& Hiller, 1998), to assess tinnitus-related psychological distress.
次要结局
- Therapy Satisfaction Scale (self-developed)(week 10)
- Therapy Expectancy Scale (self-developed)(baseline)
- Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)(6 months)
- Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)(3 months)
- Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)(baseline)
- Process evaluation items (self-developed)(18 months)
- Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)(18 months)
- Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)(18 months)
- Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)(18 months)
- Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)(18 months)
- Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)(18 months)
- Fear Avoidance Questionnaire (FAQ; self-developed)(18 months)
- Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)(2 months)
研究者
Cornelia Weise
Ph.D.
Linkoeping University