Internet-based Versus Face-to-face Clinical Care for Tinnitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: CBT-based internet-intervention for tinnitus
* Behavioral: Face-to-face clinical tinnitus care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: iCBT<br>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. | Behavioral: CBT-based internet-intervention for tinnitus<br>* Tinnitus e-learning programme<br>* Other names: iCBT;|
| Active Comparator: Face-to-face clinical tinnitus care<br>Receive individual face-to-face tinnitus care, and follow-up appointments as required. | Behavioral: Face-to-face clinical tinnitus care<br>* Hospital tinnitus counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline and at 8 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | At baseline and at 8 weeks post-intervention | 
| 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 | 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 | 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 | 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 | Assessed at baseline and 8 weeks post-intervention. both scores are reported | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Tinnitus treatment, Internet-intervention