Manualisation and feasibility study of audiologist-delivered counselling for tinnitus

ISRCTN	ISRCTN13059163
DOI	https://doi.org/10.1186/ISRCTN13059163
Protocol serial number	PB-PG-0613-31106
Sponsor	Nottingham University Hospitals NHS Trust (UK)
Funder	National Institute for Health Research

Submission date: 22/03/2016
Registration date: 06/05/2016
Last edited: 01/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Tinnitus is the experience of noises in the ears or head not related to external sound. It is incurable and is often associated with depression, anxiety, insomnia and reduced quality of life. Tinnitus is treated using a number of interventions. Sound therapy and patient education are widely available but 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 for the clinical benefit of counselling for tinnitus delivered by clinical psychologists or psychiatrists, but there is a lack of evidence for the NHS model of tinnitus care where face-to-face counselling is delivered by audiology professionals. This remains an important unanswered question given that specialist tinnitus care is increasingly becoming the domain of the audiologist. The aim of this study is to assess the feasibility of an audiologist-delivered psychological intervention for tinnitus.

Who can participate?
Adult patients with tinnitus

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives specialised care from an audiologist who has received training in the use of a manual to deliver a psychological intervention for tinnitus treatment. The other group receives usual care from an audiologist who has not trained this specialised training. The researchers evaluate the acceptability of the counselling, patient compliance with therapy, clinician compliance with the manual, willingness of patients to be randomly allocated, and whether there is sufficient interest and need for such a study. Patients and audiologists are interviewed about which elements of counselling are most/least beneficial and why.

What are the possible benefits and risks of participating?
As this stage it is not known whether one treatment is more effective than the other. The researchers cannot promise that the study will help the participants , but participation may help improve the way in which tinnitus is treated in audiology clinics. Psychological treatments are known to result in improvement in psychological wellbeing for some patients, but a small minority of patients' condition declines from beginning to end of treatment. All participants are given information about a free psychological treatment service they can contact if they wish.

Where is the study run from?
1. Nottingham University Hospitals NHS Trust (UK)
2. Derby Hospitals NHS Foundation Trust (UK)
3. Sherwood Forest Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2016 to April 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr John Taylor
2. Dr Derek Hoare

Contact information

Dr John Taylor
Public

NIHR Nottingham Hearing Biomedical Research Unit
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Dr Derek Hoare
Scientific

NIHR Nottingham Hearing Biomedical Research Unit
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Study information

Primary study design	Interventional
Study design	Multi-centre randomised feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Manualisation and feasibility study of an audiologist-delivered counselling for tinnitus
Study acronym	The TinMan study
Study objectives	Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within NHS audiology, tinnitus is treated using a number of recommended interventions but there is no standard protocol for deciding on a first line approach. Sound therapy and patient education are widely available but 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 counselling for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where face-to-face counselling is delivered by audiology professionals. This remains an important unanswered question given that specialist tinnitus care is increasingly becoming the domain of the audiologist. This is a multi-centre feasibility trial of an audiologist-delivered manualised psychological intervention for tinnitus, across three audiology departments where patients are randomised to receive either usual care or care from an audiologist who has received training in the use of the manual.
Ethics approval(s)	NHS Health Research Authority: North West - Preston Research Ethics Committee, 04/02/2016, REC ref: 16/NW/0047, IRAS Project ID: 172091
Health condition(s) or problem(s) studied	Tinnitus
Intervention	Patients with tinnitus will be randomised to receive either: 1. Specialised care from an audiologist who has received training in the use of a manual to deliver a psychological intervention for tinnitus treatment 2. Usual care (control) from an audiologist who has not trained this specialised training
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility of a full-scale randomised controlled trial is the essential outcome of the feasibility trial. Feasibility would be confirmed by: 1. A conservative recruitment rate of 10% of all eligible patients, calculated using the total number of participation invitation letters sent out 2. Recruitment of 65% of target participants in the 5-month time-frame 3. Retention of 80% of participants with an equivalent proportion of primary outcome data collected 4. Continued compliance to the manualised tinnitus counselling
Key secondary outcome measure(s)	Secondary patient-reported outcome measures for the feasibility trial include a set of measures that might be typical in a tinnitus clinical trial: 1. Severity and impact of tinnitus, measured using the Tinnitus Functional Index (TFI) 2. General well-being, measured using Clinical Outcomes in Routine Evaluation — Outcome Measure (CORE-OM) 3. Health-related quality of life, measured using Health Utilities Index Mark 3 (HUI3) 4. Overall state of health, measured using EuroQol (EQ-5D) 5. Health resource usage, measured using Client Service Receipt Inventory (CSRI) 6. Quality of the therapeutic alliance, measured using the Working Alliance Inventory (WAI), including both patient and clinician forms These will be completed at baseline, post-intervention and 6-month follow-up. Audiologists who have delivered and patients who have received the manualised care will be interviewed about their experience of the intervention and qualitative analysis will be conducted to identify which components worked well, were not useful and why?
Completion date	04/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key inclusion criteria	For inclusion in the feasibility trial patients must reflect the typical population that might be expected to take part in a Phase 2 clinical trial. All patients will: 1. Be enrolled at their first visit to audiology 2. Have a primary complaint of tinnitus 3. A clinically relevant need will be determined as a Tinnitus Functional Index (Meikle 2012) questionnaire score >24/100 which indicates tinnitus is at least a moderate problem for the patient 4. Be willing to partake in individual counselling if allocated to the specialist care arm of the study 5. Be willing to complete questionnaires at three time points 6. Take part in follow-up interviews about their experiences (if randomised to intervention)
Key exclusion criteria	1. Patients whose tinnitus is of a medically treatable origin (i.e. not chronic subjective tinnitus) 2. Patients who are unable to communicate in English
Date of first enrolment	01/07/2016
Date of final enrolment	30/11/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Nottingham University Hospitals NHS Trust

NG7 2UH
United Kingdom

Derby Hospitals NHS Foundation Trust

DE22 3NE
United Kingdom

Sherwood Forest Hospitals NHS Foundation Trust

NG17 4JL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2020	04/03/2021	Yes	No
Protocol article	protocol	15/05/2017		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Delphi study	01/03/2018	01/11/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/11/2021: Publication reference added.
04/03/2021: Publication reference added.
10/11/2017: The overall trial end date was changed from 30/04/2017 to 04/01/2018.
19/05/2017: Publication reference added.