Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial
Background Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at red...
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| Format: | Article |
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BioMed Central
2017
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| Online Access: | https://eprints.nottingham.ac.uk/48199/ |
| _version_ | 1848797712569335808 |
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| author | Beukes, Eldre W. Baguley, David Allen, Peter M. Manchaiah, Vinaya Andersson, Gerhard |
| author_facet | Beukes, Eldre W. Baguley, David Allen, Peter M. Manchaiah, Vinaya Andersson, Gerhard |
| author_sort | Beukes, Eldre W. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background
Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus.
Methods/design
This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin.
Discussion
This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. |
| first_indexed | 2025-11-14T20:08:14Z |
| format | Article |
| id | nottingham-48199 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:08:14Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-481992020-05-04T18:42:48Z https://eprints.nottingham.ac.uk/48199/ Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial Beukes, Eldre W. Baguley, David Allen, Peter M. Manchaiah, Vinaya Andersson, Gerhard Background Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. Methods/design This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. Discussion This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. BioMed Central 2017-04-21 Article PeerReviewed Beukes, Eldre W., Baguley, David, Allen, Peter M., Manchaiah, Vinaya and Andersson, Gerhard (2017) Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. Trials, 18 . 186/1-186/11. ISSN 1745-6215 Service development; Tinnitus management; Clinical intervention; Tinnitus distress; Non-inferiority trial; Tinnitus treatment; Internet intervention; Cognitive behavioural therapy; Guided intervention https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1931-6 doi:10.1186/s13063-017-1931-6 doi:10.1186/s13063-017-1931-6 |
| spellingShingle | Service development; Tinnitus management; Clinical intervention; Tinnitus distress; Non-inferiority trial; Tinnitus treatment; Internet intervention; Cognitive behavioural therapy; Guided intervention Beukes, Eldre W. Baguley, David Allen, Peter M. Manchaiah, Vinaya Andersson, Gerhard Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title | Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title_full | Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title_fullStr | Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title_full_unstemmed | Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title_short | Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| title_sort | guided internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial |
| topic | Service development; Tinnitus management; Clinical intervention; Tinnitus distress; Non-inferiority trial; Tinnitus treatment; Internet intervention; Cognitive behavioural therapy; Guided intervention |
| url | https://eprints.nottingham.ac.uk/48199/ https://eprints.nottingham.ac.uk/48199/ https://eprints.nottingham.ac.uk/48199/ |