A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study)
Abstract Background Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counse...
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doaj-4467aeb67caa4c8188ed0def43d25e562020-11-24T21:53:00ZengBMCPilot and Feasibility Studies2055-57842017-05-01311810.1186/s40814-017-0137-8A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study)John A. Taylor0Deborah A. Hall1Dawn-Marie Walker2Mary McMurran3Amanda Casey4David Stockdale5Debbie Featherstone6Dean M. Thompson7Carol MacDonald8Derek J. Hoare9National Institute for Health Research (NIHR) Nottingham Biomedical Research CentreNational Institute for Health Research (NIHR) Nottingham Biomedical Research CentreHealth Sciences, University of SouthamptonDivision of Psychiatry and Applied Psychology, School of Medicine, University of NottinghamSchool of Life and Health Sciences, Aston UniversityBritish Tinnitus AssociationClitheroe Therapies ClinicNational Institute for Health Research (NIHR) Nottingham Biomedical Research CentreDepartment of Psychology, University of StirlingNational Institute for Health Research (NIHR) Nottingham Biomedical Research CentreAbstract Background Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals. In a pilot randomised controlled trial (RCT), this study aims to evaluate the feasibility of comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment. Methods/design Phase 1 consisted of three development stages: (1) a scoping review to generate a comprehensive set of tinnitus counselling components, (2) a Delphi survey involving expert patients (n = 18) and clinicians (n = 21) to establish consensus on the essential core attributes of tinnitus counselling, and (3) incorporation of these elements into a manualised care protocol. In phase 2, following training in a dedicated workshop, the manualised intervention will be delivered by three experienced audiologists across three different sites. Patients (n = 30) will be randomly allocated to receive either (1) psychologically informed management from an audiologist trained to deliver the manualised intervention or (2) treatment as usual (TAU) from an audiologist who has not received this training. Quantitative outcome measures will be administered at baseline, discharge and 6-month follow-up. Qualitative interviews with participating patients and clinicians will be conducted to gather perspectives on the feasibility and acceptability of the manualised intervention. Discussion The feasibility of proceeding to a definitive RCT will be assessed via compliance with the manual, willingness to be randomised, number of eligible participants, rate of recruitment, retention and collection of quantitative outcome measures. This research offers an important first step to an evidence-based, standardised and accessible approach to tinnitus care. Trial registration ISRCTN13059163 . Date of registration: 6 May 2016http://link.springer.com/article/10.1186/s40814-017-0137-8TinnitusAudiologyPsychological interventionRandomised controlled trial (RCT)Manual |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
John A. Taylor Deborah A. Hall Dawn-Marie Walker Mary McMurran Amanda Casey David Stockdale Debbie Featherstone Dean M. Thompson Carol MacDonald Derek J. Hoare |
spellingShingle |
John A. Taylor Deborah A. Hall Dawn-Marie Walker Mary McMurran Amanda Casey David Stockdale Debbie Featherstone Dean M. Thompson Carol MacDonald Derek J. Hoare A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) Pilot and Feasibility Studies Tinnitus Audiology Psychological intervention Randomised controlled trial (RCT) Manual |
author_facet |
John A. Taylor Deborah A. Hall Dawn-Marie Walker Mary McMurran Amanda Casey David Stockdale Debbie Featherstone Dean M. Thompson Carol MacDonald Derek J. Hoare |
author_sort |
John A. Taylor |
title |
A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) |
title_short |
A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) |
title_full |
A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) |
title_fullStr |
A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) |
title_full_unstemmed |
A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study) |
title_sort |
psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (tin man study) |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2017-05-01 |
description |
Abstract Background Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals. In a pilot randomised controlled trial (RCT), this study aims to evaluate the feasibility of comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment. Methods/design Phase 1 consisted of three development stages: (1) a scoping review to generate a comprehensive set of tinnitus counselling components, (2) a Delphi survey involving expert patients (n = 18) and clinicians (n = 21) to establish consensus on the essential core attributes of tinnitus counselling, and (3) incorporation of these elements into a manualised care protocol. In phase 2, following training in a dedicated workshop, the manualised intervention will be delivered by three experienced audiologists across three different sites. Patients (n = 30) will be randomly allocated to receive either (1) psychologically informed management from an audiologist trained to deliver the manualised intervention or (2) treatment as usual (TAU) from an audiologist who has not received this training. Quantitative outcome measures will be administered at baseline, discharge and 6-month follow-up. Qualitative interviews with participating patients and clinicians will be conducted to gather perspectives on the feasibility and acceptability of the manualised intervention. Discussion The feasibility of proceeding to a definitive RCT will be assessed via compliance with the manual, willingness to be randomised, number of eligible participants, rate of recruitment, retention and collection of quantitative outcome measures. This research offers an important first step to an evidence-based, standardised and accessible approach to tinnitus care. Trial registration ISRCTN13059163 . Date of registration: 6 May 2016 |
topic |
Tinnitus Audiology Psychological intervention Randomised controlled trial (RCT) Manual |
url |
http://link.springer.com/article/10.1186/s40814-017-0137-8 |
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