A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study)
Research output: Contribution to journal › Article › peer-review
Colleges, School and Institutes
- Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
- Health Sciences, University of Southampton, Southampton, SO17 1BJ UK.
- Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
- Aston University
- British Tinnitus Association, Ground Floor, Unit 5, Acorn Business Park, Woodseats Close, Sheffield, S8 0TB UK.
- Clitheroe Therapies Clinic, 3 Castlegate, Clitheroe, Lancashire BB7 1AZ UK.
- Department of Psychology, University of Stirling, Stirling, FK9 4LA UK.
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.
|Journal||Pilot and Feasibility Studies|
|Publication status||Published - 15 May 2017|