Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- The Tinnitus Functional Index
研究概览
简要总结
The purpose of this study is to compare the effectiveness of a CBT-based internet intervention with face to face standard clinical care 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 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) compared to standard face-to-face clinical care.
Design A two-armed Randomized Control Trial (RCT), will be used to evaluate the effectiveness iCBT on tinnitus distress. Participants placed in the experimental group will receive iCBT and those in the control group will undergo standard face-to-face hospital based clinical care.
Setting: This will be an multi-center study, recruiting from three tinnitus clinics in the East of England, UK; namely: Norfolk and Norwich University Hospital Trust, Milton Keynes University Hospital and Hinchingbrooke Healthcare NHS Trust
Participants: Recruitment will be undertaken from 3 separate clinical settings. Adult patients seen by ENT Consultants or Audiologist at these centers who mention being significantly bothered by tinnitus, and who would normally be referred for tinnitus services will be considered for the study. 80 Participants will be recruited and will be randomly assigned to either receiving face-to-face clinical clinical care consisting or or internet-based intervention (iCBT).
Intervention:
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
- •Attending either Norfolk and Norwich University Hospital, Milton Keynes University Hospital or Hinchingbrooke Hospitals as recruitment is via these hospitals
- •The ability to read and type in English
- •No barriers to using a computer (e.g. significant fine motor control or visual problems)
- •Internet and e-mail access, and the ability to use these
- •Commitment to completing the programme
- •Completion of the online screening and outcome questionnaires
- •Agreeing to participate in either group and be randomized to one of these groups
- •Understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same
排除标准
- •Reporting any major medical or psychiatric conditions
- •Reporting pulsatile, objective or unilateral tinnitus, which have not been investigated medically
- •Tinnitus as a consequence of a medical disorder, still under investigation
- •Undergoing any tinnitus therapy concurrently to partaking in this study
研究组 & 干预措施
Experimental group: iCBT
CBT-based internet-intervention for tinnitus 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.
干预措施: CBT-based internet-intervention for tinnitus (Behavioral)
Face-to-face clinical tinnitus care
Receive individual face-to-face tinnitus care, and follow-up appointments as required.
干预措施: Face-to-face clinical tinnitus care (Behavioral)
结局指标
主要结局
The Tinnitus Functional Index
时间窗: At baseline and at 8 weeks post-intervention
A self-reported outcome measure of tinnitus severity. 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 out of 100 is reported and not any subscales Scores below 25 indicate mild tinnitus, from 25-50 indicated significant tinnitus and from 50-100 severe tinnitus
次要结局
- Cognitive Failures Questionnaire(Assessed at baseline and 8 weeks post-intervention)
- Generalised Anxiety Disorder(At baseline and at 8 weeks post-intervention. Both scores are reported)
- Hyperacusis Questionnaire(At baseline and at 8 weeks post-intervention. both scores are reported)
- Insomnia Severity Index(Assessed at baseline and 8 weeks post-intervention. both scores are reported)
- Satisfaction With Life Scale(Assessed at baseline and 8 weeks post-intervention. Both scores are reported)
- Tinnitus Handicap Inventory(Assessed at baseline and 8 weeks post-intervention. Both time points are reported)
- Patient Health Questionnaire(At baseline and at 8 weeks post-intervention)
- Hearing Handicap Inventory(At baseline and at 8 weeks post-intervention)