Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial
Importance: Accessible clinical care is not always available to those with distressing tinnitus. Internet-based cognitive behavioural therapy has potential to increase access to evidence-based tinnitus services. Research comparing the effectiveness of this intervention with face to face care is requ...
| Main Authors: | , , , , |
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| Format: | Article |
| Published: |
American Medical Association
2018
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| Online Access: | https://eprints.nottingham.ac.uk/54957/ |
| _version_ | 1848799088878813184 |
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| author | Beukes, Eldre W. Andersson, Gerhard Allen, Peter M. Manchaiah, Vinaya Baguley, David |
| author_facet | Beukes, Eldre W. Andersson, Gerhard Allen, Peter M. Manchaiah, Vinaya Baguley, David |
| author_sort | Beukes, Eldre W. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Importance: Accessible clinical care is not always available to those with distressing tinnitus. Internet-based cognitive behavioural therapy has potential to increase access to evidence-based tinnitus services. Research comparing the effectiveness of this intervention with face to face care is required.
Objective: To evaluate whether an Internet-based cognitive behavioural therapy intervention is at least as effective as established individualized face-to-face care in reducing tinnitus distress and tinnitus-related difficulties.
Design: A randomized, multi-centre, two-arm parallel group, non-inferiority trial with 2-month follow-up was run between October 2016 and July 2017. Participants were randomly assigned (1:1) to either intervention using variable permuted block sizes of four and six.
Setting: The experimental group received the Internet-intervention online while the active control undertook the usual face-to-face tinnitus care at one of three UK-based National Health Service hospitals.
Participants: Adults that had been referred to their local tinnitus clinics due to bothersome tinnitus, were invited to participate (n =374). 92 participants were randomized (experimental n = 46; control n= 46), of which 88 completed the immediate post-intervention assessment and 72 completed follow-up assessment measures.
Interventions: Participants were randomized to receive either 8 weeks of guided Internet-based cognitive behavioural therapy or 2-3 individualized face-to-face appointments in a tinnitus clinic.
Main Outcome measures: The primary outcome was a change in tinnitus distress (as assessed by the Tinnitus Functional Index). Secondary assessment measures were included for insomnia, anxiety, depression, hearing disability, hyperacusis, cognitive failures, and satisfaction with life.
Results: The between-group difference in the Tinnitus Functional Index scores at post-intervention of 5.19 (95% CI -4.17 to 14.53) and 5.18 (95% CI -4.17 to 14.53) at follow-up, fell within the non-inferiority margin of 13 points for the lower 95% confidence interval. For the secondary outcomes, only outcomes for insomnia fell outside the non-inferiority margin, at both post-intervention and follow-up, favouring the iCBT group.
Conclusions and Relevance: This is the first trial to compare an Internet-based intervention with standard individualized care for tinnitus. It demonstrates that both interventions were equally effective for reducing tinnitus distress and most tinnitus-related difficulties.
Trial Registration Clinicaltrials.gov: Identifier: NCT02665975 |
| first_indexed | 2025-11-14T20:30:07Z |
| format | Article |
| id | nottingham-54957 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:30:07Z |
| publishDate | 2018 |
| publisher | American Medical Association |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-549572019-02-04T11:40:46Z https://eprints.nottingham.ac.uk/54957/ Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial Beukes, Eldre W. Andersson, Gerhard Allen, Peter M. Manchaiah, Vinaya Baguley, David Importance: Accessible clinical care is not always available to those with distressing tinnitus. Internet-based cognitive behavioural therapy has potential to increase access to evidence-based tinnitus services. Research comparing the effectiveness of this intervention with face to face care is required. Objective: To evaluate whether an Internet-based cognitive behavioural therapy intervention is at least as effective as established individualized face-to-face care in reducing tinnitus distress and tinnitus-related difficulties. Design: A randomized, multi-centre, two-arm parallel group, non-inferiority trial with 2-month follow-up was run between October 2016 and July 2017. Participants were randomly assigned (1:1) to either intervention using variable permuted block sizes of four and six. Setting: The experimental group received the Internet-intervention online while the active control undertook the usual face-to-face tinnitus care at one of three UK-based National Health Service hospitals. Participants: Adults that had been referred to their local tinnitus clinics due to bothersome tinnitus, were invited to participate (n =374). 92 participants were randomized (experimental n = 46; control n= 46), of which 88 completed the immediate post-intervention assessment and 72 completed follow-up assessment measures. Interventions: Participants were randomized to receive either 8 weeks of guided Internet-based cognitive behavioural therapy or 2-3 individualized face-to-face appointments in a tinnitus clinic. Main Outcome measures: The primary outcome was a change in tinnitus distress (as assessed by the Tinnitus Functional Index). Secondary assessment measures were included for insomnia, anxiety, depression, hearing disability, hyperacusis, cognitive failures, and satisfaction with life. Results: The between-group difference in the Tinnitus Functional Index scores at post-intervention of 5.19 (95% CI -4.17 to 14.53) and 5.18 (95% CI -4.17 to 14.53) at follow-up, fell within the non-inferiority margin of 13 points for the lower 95% confidence interval. For the secondary outcomes, only outcomes for insomnia fell outside the non-inferiority margin, at both post-intervention and follow-up, favouring the iCBT group. Conclusions and Relevance: This is the first trial to compare an Internet-based intervention with standard individualized care for tinnitus. It demonstrates that both interventions were equally effective for reducing tinnitus distress and most tinnitus-related difficulties. Trial Registration Clinicaltrials.gov: Identifier: NCT02665975 American Medical Association 2018-07-18 Article PeerReviewed Beukes, Eldre W., Andersson, Gerhard, Allen, Peter M., Manchaiah, Vinaya and Baguley, David (2018) Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial. JAMA Otolaryngology–Head & Neck Surgery . ISSN 2168-619X (In Press) |
| spellingShingle | Beukes, Eldre W. Andersson, Gerhard Allen, Peter M. Manchaiah, Vinaya Baguley, David Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title | Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title_full | Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title_fullStr | Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title_full_unstemmed | Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title_short | Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| title_sort | guided internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial |
| url | https://eprints.nottingham.ac.uk/54957/ |