A CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom

Study Overview
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Brief Summary
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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

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 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. Hypothesis: If this intervention proves feasible it is and effective, 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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CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: CBT-based internet-intervention for tinnitus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participant's eligibility for the study is as follows: Aged 18 years and over living in the UK 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 Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire Suffering with tinnitus for a minimum period of 3 months Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index) 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<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>* 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.<br>* Other names: iCBT;|
| Other: weekly check-in group with delayed treatment<br>will complete weekly measures and commence the treatment once the experimental group completes the intervention | Behavioral: CBT-based internet-intervention for tinnitus<br>* 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.<br>* Other names: iCBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Tinnitus Functional Index | 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 | Assessed at baseline and 8 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory-screening Version | Measure of tinnitus severity to use as a weekly measure Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI-S Minimal value: 0 Maximum value 40 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 | 
| Insomnia Severity Index | Measure of sleep problems Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 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 | 
| 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 | 
| Satisfaction With Life | Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better 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 Units are scores on a scale Total score used, not sub scales | Assessed at baseline and 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 Units are scores on a scale Total score used, not sub scales | Assessed at baseline and 8 weeks post-intervention | 
| Hyperacusis Questionnaire | Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 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 | 
| Hearing Handicap Inventory- Screening Version | 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 Units are scores on a scale Total score used, not sub scales | Assessed at baseline and 8 weeks post-intervention | 

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