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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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. |
|
| weekly check-in group with delayed treatment | Other | will complete weekly measures and commence the treatment once the experimental group completes the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-based internet-intervention for tinnitus | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria
Participant's eligibility for the study is as follows:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Peter Allen | Anglia Ruskin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision and hearing Sciences, Anglia Ruskin Univeristy | Cambridge | CB1 1PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41854598 | Derived | Beukes E, Andersson G, Manchaiah V. Long-Term Outcomes of an Internet-Based Cognitive Behavior Therapy Intervention for Tinnitus: Follow-Up Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 May 1;152(5):503-512. doi: 10.1001/jamaoto.2026.0094. | |
| 34417217 | Derived | Rodrigo H, Beukes EW, Andersson G, Manchaiah V. Internet-based cognitive-behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes. BMJ Open. 2021 Aug 20;11(8):e049384. doi: 10.1136/bmjopen-2021-049384. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt. |
| FG001 | Control Group | During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 3 more participants recruited per group (73 instead of 70) in case of additional drop-outs
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intention to treat paradigm | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
8 weeks post intervention and 1 year post intervention. Data collected: All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Higher level of anxiety | General disorders | Serious | Systematic Assessment |
Participants were recruited from the general public due to interest in undertaking an Internet-intervention and not from a clinical setting. The demographical distribution showed more male participants, a slightly higher mean age distribution and longer tinnitus duration than those reported by previous iCBT trials on tinnitus. Second, the likelihood of type I errors cannot be excluded due to multiplicity of testing. Third, not all participants completed the outcome measures
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eldre Beukes | Anglia Ruskin Univeristy | 1223698847 | 2847 | eldre.beukes@anglia.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2015 | Jan 8, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2015 | Jul 4, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| 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 |
| 29095725 | Derived | Beukes EW, Baguley DM, Allen PM, Manchaiah V, Andersson G. Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Adults With Tinnitus in the United Kingdom: A Randomized Controlled Trial. Ear Hear. 2018 May/Jun;39(3):423-433. doi: 10.1097/AUD.0000000000000505. |
| 26399571 | Derived | Beukes EW, Manchaiah V, Allen PM, Baguley DM, Andersson G. Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial. BMJ Open. 2015 Sep 23;5(9):e008241. doi: 10.1136/bmjopen-2015-008241. |
| BG001 | Weekly check-in Group | will complete weekly measures and commence the treatment once the experimental group completes the intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Tinnitus Severity at baseline | Measure Description: A measure of tinnitus severity. Measured on a scale of 0 to 100. Lower scores indicate less severe tinnitus. A score of 25 or higher indicates the need for an intervention. A score of 50 or above indicates severe tinnitus. If post-intervention scores are lower than baseline it indicates an improvement. | Mean | Standard Deviation | Score on a scale (0-100) |
|
| Control Group |
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm |
|
|
| Secondary | 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 | Intention to treat analysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
|
|
| Secondary | 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 | Intention to treat analysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
|
|
| Secondary | 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 | Intention to treat analysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
|
|
| Secondary | 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 | Intention to treat | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
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|
|
| Secondary | 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 | Intention to treat | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
|
|
| Secondary | 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 | intention to treat anlaysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
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|
|
| Secondary | 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 | Intention to treat analysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
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|
|
| Secondary | 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 | Intention to treat analysis | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 8 weeks post-intervention |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Control Group | During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm | 0 | 73 | 0 | 73 | 0 | 73 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |