The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus

Abstract

Objective

To develop a manualised psychological treatment for tinnitus that could enhance audiologist usual care, and to test feasibility of evaluating it in a randomised controlled trial.

Design

Feasibility trial, random allocation of patients to manualised treatment or treatment as usual, and mixed-methods evaluation.

Study sample: Senior audiologists, and adults with chronic tinnitus.

Results

Recruitment reached 63% after 6 months (feasibility pre-defined as 65%). Only nine patients (47%) were retained for the duration of the trial. Patients reported that the treatment was acceptable and helped reassure them about their tinnitus. Audiologists reported mixed feelings about the kinds of techniques that are presented to them as ‘psychologically informed’. Audiologists also reported lacking confidence because the training they had was brief, and stated that more formal supervision would have been helpful to check adherence to the treatment manual.

Conclusions

The study indicate potential barriers to audiologist use of the manual, and that a clinical trial of the intervention is not yet feasible. However, positive indications from outcome measures suggest that further development work would be worthwhile. Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required.

Trial Registration: ISRCTN13059163.

Keywords:

• Tinnitus
• audiology
• psychological intervention
• randomised controlled trial (RCT)
• Manual

Acknowledgements

We acknowledge the support of the National Institute for Health Research Clinical Research network (CRN) in participant recruitment. Nottingham University Hospitals NHS Trust was the Sponsor for this study. Richard Nicholson, Michelle Booth, and Tendai Ngwerume were local principal investigators at the three trial sites. Debra Williams and Hannah Heath from the patient steering group contributed to manual development. Amber Breame, Jade McCune, and Jan Kelly managed the randomisation. Iskra Potgieter transcribed interview recordings. Anna Frost and Chris Almey contributed to thematic analysis of patient interviews.

Disclosure statement

None.

Additional information

Funding

This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme [Grant Reference Number PB-PG-0613-31106]. DAH is an NIHR Senior Investigator. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.