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An online program to address tinnitus severity and distress in adults with bothersome tinnitus.

Tune Out: A randomised controlled trial to investigate the impact of an online program on tinnitus severity, handicap, and psychological symptoms in adults with tinnitus.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000424404
Enrollment
88
Registered
2025-05-08
Start date
2025-06-04
Completion date
2025-10-16
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to test the benefit of an online tinnitus management program. In this research, adults living with bothersome tinnitus will complete a set of questionnaires measuring tinnitus severity and wellbeing. We will use randomisation to decide who joins the program right away and who waits. By comparing those who start the program immediately with those who wait, we can accurately see if the program really works and how it might help people. Participants in both groups complete follow-up questionnaires at six weeks and three months to what changes occur. It is expected that participants who receive the program in this time will have reduced tinnitus distress following intervention, compared to the control group.

Interventions

In this randomised controlled trial, adults with diagnosed or self-reported tinnitus will complete a set of baseline questionnaires measuring tinnitus severity, psychological symptoms, and participant characteristics (i.e., demographics). Participants will be randomised into an intervention group (six weeks access to Tune Out) or control group (waitlist). Participants in both groups complete follow-up questionnaires at six weeks and three months to determine change in tinnitus severity and psych

In this randomised controlled trial, adults with diagnosed or self-reported tinnitus will complete a set of baseline questionnaires measuring tinnitus severity, psychological symptoms, and participant characteristics (i.e., demographics). Participants will be randomised into an intervention group (six weeks access to Tune Out) or control group (waitlist). Participants in both groups complete follow-up questionnaires at six weeks and three months to determine change in tinnitus severity and psychological symptoms. The Tune Out program is an online self-guided, cognitive behaviour therapy (CBT)-based program that consists of educational content about tinnitus, CBT-based guidance, exercises, and a workbook. The program is a publicly available resource at www.tuneout.com.au. There are no strict engagement requirements for accessing the Tune Out program throughout the trial, however website analytics will be analysed to determine frequency of use, modules completed, and adherence to the program.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be diagnosed with or self-report tinnitus. Participants must have consulted an audiologist or medical practitioner regarding their tinnitus. Participants are aged 18 years and over. Participants reside in Australia.

Exclusion criteria

Due to physical, intellectual, or linguistic circumstances is unable to provide informed consent or successfully complete enrolment questionnaire.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026