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Trial registered on ANZCTR


Registration number
ACTRN12625000424404p
Ethics application status
Submitted, not yet approved
Date submitted
8/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An online program to address tinnitus severity and distress in adults with bothersome tinnitus.
Scientific title
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.
Secondary ID [1] 314163 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 336995 0
Condition category
Condition code
Ear 333462 333462 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330757 0
Behaviour
Intervention code [2] 330758 0
Lifestyle
Intervention code [3] 330760 0
Treatment: Other
Comparator / control treatment
Participants in the control group will be waitlisted to receive the Tune Out program at the end of the trial. This reflects a typical approach to tinnitus management in which no action is taken and the tinnitus awareness / intrusiveness may lessen with time.
Control group
Active

Outcomes
Primary outcome [1] 341034 0
Tinnitus severity (composite primary outcome consisting of eight subscales: intrusiveness, sense of control, cognitive interference, sleep disturbance, auditory difficulties, relaxation, quality of life, and emotional distress)
Timepoint [1] 341034 0
Baseline, six weeks post-baseline (primary endpoint), three months post-baseline.
Secondary outcome [1] 445881 0
Tinnitus handicap (composite score and subscales for functional limitations, emotional responses, and catastrophic reaction)
Timepoint [1] 445881 0
Baseline, six weeks post-baseline, three months post-baseline
Secondary outcome [2] 445882 0
Psychological symptoms (composite score and subscales for depression, anxiety and stress)
Timepoint [2] 445882 0
Baseline, six weeks post-baseline, three months post-baseline
Secondary outcome [3] 445883 0
Self-efficacy
Timepoint [3] 445883 0
Baseline, six weeks post-baseline, three months post-baseline
Secondary outcome [4] 445884 0
Digital intervention usability
Timepoint [4] 445884 0
Six weeks post-baseline

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Due to physical, intellectual, or linguistic circumstances is unable to provide informed consent or successfully complete enrolment questionnaire.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computerised concealed randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A tentative a priori power analysis was performed in G*Power 3.1.9.7 (Faul et al., 2007) of the primary treatment outcome of tinnitus severity as measured by the Tinnitus Functional Index (TFI) suggested a total sample size of N=86 was required to detect a medium effect size (Cohen’s f = 0.25) at an alpha of 0.05 and power of 0.8 using repeated-measures, between-factors ANOVA.
Descriptive statistics will summarise the profile of study participants. These will be presented as frequencies and percentages for categorical variables; means, standard deviations, medians and ranges for variables measured on a continuous scale.
Quantitative efficacy data will be analysed using an intention to treat (ITT) analysis and linear mixed model approaches to determine indicators of reliable clinical change and the effect sizes in change in tinnitus severity pre- and post-intervention, and differences between intervention and control groups. Significant program impact will be determined by the significance and effect size of the change in the primary outcome variable.
Multivariate multiple linear regression will be conducted to explore possible impact of demographic characteristics and recruitment pathways on the efficacy of the intervention.
Baseline comparison of groups (those who provided follow-up data and those that did not) will be compared to determine if there are group differences that may explain loss to follow-up. Participants with missing data will be excluded from analysis however, sensitivity analysis will be used to quantify the effect of missing outcome data (e.g., using multiple imputation, regression adjustment or inverse probability weighting) on study results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
14/07/2025
Actual
Date of last data collection
Anticipated
20/10/2025
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318675 0
University
Name [1] 318675 0
La Trobe University
Country [1] 318675 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 321098 0
None
Name [1] 321098 0
Address [1] 321098 0
Country [1] 321098 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317288 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317288 0
Ethics committee country [1] 317288 0
Australia
Date submitted for ethics approval [1] 317288 0
08/04/2025
Approval date [1] 317288 0
Ethics approval number [1] 317288 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140578 0
Dr Emma Laird
Address 140578 0
Room 328, Level 3, Health Sciences 1 La Trobe University, Bundoora, 3086, Victoria, Australia
Country 140578 0
Australia
Phone 140578 0
+61 0394791820
Fax 140578 0
Email 140578 0
[email protected]
Contact person for public queries
Name 140579 0
Dr Emma Laird
Address 140579 0
Room 328, Level 3, Health Sciences 1 La Trobe University, Bundoora, 3086, Victoria, Australia
Country 140579 0
Australia
Phone 140579 0
+61 0394791820
Fax 140579 0
Email 140579 0
[email protected]
Contact person for scientific queries
Name 140580 0
Dr Emma Laird
Address 140580 0
Room 328, Level 3, Health Sciences 1 La Trobe University, Bundoora, 3086, Victoria, Australia
Country 140580 0
Australia
Phone 140580 0
+61 0394791820
Fax 140580 0
Email 140580 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
Immediately following all publication outputs. No end date determined.

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr Emma Laird [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24616Ethical approval  [email protected]
24617Informed consent form  [email protected]
24618Study protocol  [email protected]



Results publications and other study-related documents

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Documents added automatically
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