Manualisation and feasibility study of audiologist-delivered counselling for tinnitus

Not Applicable

Completed

• Conditions: Tinnitus; Ear, Nose and Throat

• Registration Number: ISRCTN13059163
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28515957 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32678998/ results (added 04/03/2021) 2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/28930785/ Delphi study (added 01/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-06
• Study Completion: 2018-01-04
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility of a full-scale randomised controlled trial is the essential outcome of the feasibility trial. Feasibility would be confirmed by:<br> 1. A conservative recruitment rate of 10% of all eligible patients, calculated using the total number of participation invitation letters sent out<br> 2. Recruitment of 65% of target participants in the 5-month time-frame<br> 3. Retention of 80% of participants with an equivalent proportion of primary outcome data collected<br> 4. Continued compliance to the manualised tinnitus counselling<br>