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 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
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 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 measure
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:
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?
Overall trial start date
01/05/2016
Overall trial end date
04/01/2018
Reason abandoned (if study stopped)
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 three 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 three 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
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
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
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28515957