Tinnitus Ear, Nose and Throat Tinnitus
Conditions
Interventions
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 interve
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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? | — |
Countries
England, United Kingdom
Contacts
Public ContactJohn Taylor
Outcome results
None listed