CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- The Tinnitus Functional Index
研究概览
简要总结
The purpose of this study is to determine the feasibility and effectiveness of a CBT-based internet intervention for adults with tinnitus in the United Kingdom
详细描述
Objectives Tinnitus is one of the most distressing disabilities and innovative ways of managing the related health care burden is required. A cognitive behavioural therapy (CTB) based internet intervention (iCBT) has been developed in Europe to improve access to tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus in the United Kingdom (UK). It furthermore, aims to establish for which subgroups of tinnitus suffers this iCBT intervention would be a suitable intervention.
Design A two-armed Randomized Control Trial (RCT), with a one year follow-up design will be used to evaluate the effectiveness iCBT on tinnitus distress Setting: This will be an internet-based study for adults with tinnitus living in the UK
Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 70 participants will be recruited for each group and will be randomly assigned using a computer generated randomization schedule by an independent research assistant after being pre-stratified for age and tinnitus severity.
Intervention: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
Outcome measures: The main outcome measure is the Tinnitus Functional Index. Secondary outcome measures are the Tinnitus Handicap Inventory- Screening version and self-reported measures for insomnia, hearing disability, cognitive functioning, hyperacusis, anxiety and depression and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Tinnitus Functional Index
时间窗: Assessed at baseline and 8 weeks post-intervention
Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation TFI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
次要结局
- Insomnia Severity Index(Assessed at baseline and 8 weeks post-intervention)
- Satisfaction With Life(Assessed at baseline and 8 weeks post-intervention)
- Tinnitus Handicap Inventory-screening Version(Assessed at baseline and 8 weeks post-intervention)
- Cognitive Failures Questionnaire(Assessed at baseline and 8 weeks post-intervention)
- Patient Health Questionnaire(Assessed at baseline and 8 weeks post-intervention)
- Generalised Anxiety Disorder(Assessed at baseline and 8 weeks post-intervention)
- Hyperacusis Questionnaire(Assessed at baseline and 8 weeks post-intervention)
- Hearing Handicap Inventory- Screening Version(Assessed at baseline and 8 weeks post-intervention)
研究者
Eldre Beukes
Mrs Eldre Wiida Beukes
Anglia Ruskin University