Condition category
Ear, Nose and Throat
Date applied
22/03/2016
Date assigned
06/05/2016
Last edited
10/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 test 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. We 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 we are uncertain whether one treatment will be more effective than the other. We cannot promise that the study will help the participants , but participation may help us improve the way in which tinnitus is managed in audiology clinics. Psychological therapies are known to result in improvement in psychological wellbeing for some patients, however a small minority of patient’s condition declines from beginning to end of treatment. All participants will be given information about a free psychological therapies service they can contact if they wish.

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

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

Trial website

Contact information

Type

Public

Primary contact

Dr John Taylor

ORCID ID

Contact details

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

Type

Scientific

Additional contact

Dr Derek Hoare

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0613-31106

Study information

Scientific title

Manualisation and feasibility study of an audiologist-delivered counselling for tinnitus

Acronym

The TinMan study

Study hypothesis

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

NHS Health Research Authority: North West - Preston Research Ethics Committee, 04/02/2016, REC ref: 16/NW/0047, IRAS Project ID: 172091

Study design

Multi-centre randomised feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

Secondary patient reported outcome measures for the feasibility trial include a set of measures that might be typical in a tinnitus clinical trial. We have selected:
1. The Tinnitus Functional Index (TFI) to measure the severity and impact of tinnitus
2. Clinical Outcomes in Routine Evaluation — Outcome Measure (CORE-OM) to assess general well-being
3. Health Utilities Index Mark 3 (HUI3) to assess health-related quality of life
4. EuroQol (EQ-5D) to assess overall state of health
5. Client Service Receipt Inventory (CSRI) as a measure of health resource usage
6. The Working Alliance Inventory (WAI) as a measure of the quality of the therapeutic alliance, 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?

Overall trial start date

01/05/2016

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant 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 3 time points
6. Take part in follow-up interviews about their experiences (if randomised to intervention)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 (15 intervention and 15 control participants across 3 sites)

Participant 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

Recruitment start date

01/07/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
NG7 2UH
United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
DE22 3NE
United Kingdom

Trial participating centre

Sherwood Forest Hospitals NHS Foundation Trust
NG17 4JL
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Trust Headquarters
QMC Campus
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We are intending to publish:
1. Scoping literature review – already submitted
2. Protocol for Delphi survey – already submitted
3. Delphi survey results (June 2016)
4. Protocol for manualisation phase/feasibility trial (June 2016)
5. Feasibility trial results (both quantitative and qualitative elements) (May 2017). Also possible PPI dissemination at INVOLVE conference (November 2016). There will also be the NIHR report to the funder (May 2017)

Intention to publish date

01/05/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes