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.
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: i) iCBT group: This group will undergo 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. ii) Standard clinical care group: receive individual face-to-face tinnitus appointment providing the care deemed most important to this individual and follow-up appointments as required. 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. These will be measured at baseline, 3 months post- intervention and 6-months post- intervention, to assess the intervention effects over time. Hypothesis: If iCBT proves feasible and is effective compared to standard clinical care, it may have implications for the way tinnitus suffers are managed in the UK. It may be that a subset of tinnitus suffers can be managed though an e-learning treatment program, freeing up services for those with more severe problems that need face to face treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Tinnitus e-learning programme
Hospital tinnitus counselling
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Hinchingbrooke Hospital
Huntingdon, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
The Tinnitus Functional Index
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
Time frame: At baseline and at 8 weeks post-intervention
Tinnitus Handicap Inventory
Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. Both time points are reported
Satisfaction With Life Scale
Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. Both scores are reported
Cognitive Failures Questionnaire
Measure of how cognitive difficulties such as concentration and memory Units of measurement: scores on a scale Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention
Patient Health Questionnaire
Measure of signs of depressive disorders Units of measurement: scores on a scale Minimal value: 0 Maximum value 28 Higher score is a worse outcome Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention
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Generalised Anxiety Disorder
Measure of anxiety disorder and traits Units of measurement: scores on a scale Minimal value: 0 Maximum value 21 Higher score is a worse outcome Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention. Both scores are reported
Hyperacusis Questionnaire
Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Hotal score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention. both scores are reported
Hearing Handicap Inventory
Measure of hearing difficulties or hearing disability using a screening tool Units of measurement: scores on a scale Minimal value: 0 Maximum value 40 Higher score is a worse outcome Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention
Insomnia Severity Index
Measure of sleep problems Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. both scores are reported