Comparison of the Efficacy of an Internet-based Self-help Training and a Well-established Outpatient Group Therapy for the Treatment of 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
- 128
- 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 aim of this study is to compare the efficacy of an internet-based guided self-help training for chronic tinnitus with a well-established outpatient group therapy and a discussion forum group.
详细描述
Chronic tinnitus can result in significant psychological suffering and reduce quality of life. Cognitive behavioral therapy (CBT) has been shown to be effective in decreasing the impairment caused by tinnitus. One recent way delivering CBT is an internet-based self-help intervention. Internet interventions for patients with chronic tinnitus, developed by Swedish scientists, showed promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). The main purpose of this study is to compare the efficacy of this internet-based self-help training for chronic tinnitus with a traditional well-established CBT group treatment and with a discussion forum group in a randomized controlled trial. Secondary goals are a process evaluation of both treatments, the identification of predictors of treatment success, an estimation of the cost-effectiveness of each treatment and the validation of the Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005).
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 18 or above on the Tinnitus Handicap Inventory (THI) or scoring 12 or above in 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 training
- •Being able to attend weekly group sessions in the Outpatient Department of the Psychological Institute of the University of Mainz, Germany
- •Sufficient time and motivation to work on the treatment programs
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
- Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)(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 measure)(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)
- Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)(2 months)
- Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)(18 months)
- Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)(6 months)
- Therapy Expectancy Scale (self-developed)(baseline)
- Therapy Satisfaction Scale (self-developed)(week 10)
- 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)
研究者
Maria Kleinstäuber
Dr.
Johannes Gutenberg University Mainz