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Pilot Feasibility Stud. 2017 May 15;3:24. doi: 10.1186/s40814-017-0137-8. eCollection 2017.

A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study).

Pilot and feasibility studies

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

Affiliations

  1. National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU UK.
  2. Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
  3. Health Sciences, University of Southampton, Southampton, SO17 1BJ UK.
  4. Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
  5. School of Life and Health Sciences, Aston University, Birmingham, B4 7ET UK.
  6. British Tinnitus Association, Ground Floor, Unit 5, Acorn Business Park, Woodseats Close, Sheffield, S8 0TB UK.
  7. Clitheroe Therapies Clinic, 3 Castlegate, Clitheroe, Lancashire BB7 1AZ UK.
  8. Department of Psychology, University of Stirling, Stirling, FK9 4LA UK.

PMID: 28515957 PMCID: PMC5430602 DOI: 10.1186/s40814-017-0137-8

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 (

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.

Keywords: Audiology; Manual; Psychological intervention; Randomised controlled trial (RCT); Tinnitus

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