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TinnitusNCT02370810

A CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom

A study testing CBT-based internet-intervention for tinnitus in people with Tinnitus, run by Anglia Ruskin University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the feasibility and effectiveness of a CBT-based internet intervention for adults with tinnitus in the United Kingdom Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tinnitus
What is being tested?
CBT-based internet-intervention for tinnitus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2016to Sep 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant's eligibility for the study is as follows:
  • Aged 18 years and over living in the UK
  • The ability to read and type in English
  • No barriers to using a computer (e.g. significant fine motor control or visual problems)
  • Internet and e-mail access, and the ability to use these
  • Commitment to completing the programme
Show all 12Show fewer
  • Completion of the online screening and outcome questionnaires
  • Agreeing to participate in either group and be randomized to one of these groups
  • Understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same
  • Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire
  • Suffering with tinnitus for a minimum period of 3 months
  • Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index)

Who cannot join

  • Reporting any major medical or psychiatric conditions
  • Reporting pulsatile, objective or unilateral tinnitus, which have not been investigated medically
  • Tinnitus as a consequence of a medical disorder, still under investigation
  • Undergoing any tinnitus therapy concurrently to partaking in this study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Vision and hearing Sciences, Anglia Ruskin Univeristy

    Cambridge, CB1 1PT

Other trials in United Kingdom

About this study

Official title: CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial

The purpose of this study is to determine the feasibility and effectiveness of a CBT-based internet intervention for adults with tinnitus in the United Kingdom

Read the detailed description

Objectives Tinnitus is one of the most distressing disabilities and innovative ways of managing the related health care burden is required. A cognitive behavioural therapy (CTB) based internet intervention (iCBT) has been developed in Europe to improve access to tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus in the United Kingdom (UK). It furthermore, aims to establish for which subgroups of tinnitus suffers this iCBT intervention would be a suitable intervention.

Design A two-armed Randomized Control Trial (RCT), with a one year follow-up design will be used to evaluate the effectiveness iCBT on tinnitus distress Setting: This will be an internet-based study for adults with tinnitus living in the UK

Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 70 participants will be recruited for each group and will be randomly assigned using a computer generated randomization schedule by an independent research assistant after being pre-stratified for age and tinnitus severity.

Intervention: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.

Outcome measures: The main outcome measure is the Tinnitus Functional Index. Secondary outcome measures are the Tinnitus Handicap Inventory- Screening version and self-reported measures for insomnia, hearing disability, cognitive functioning, hyperacusis, anxiety and depression and quality of life.

Hypothesis: If this intervention proves feasible it is and effective, it may have implications for the way tinnitus suffers are managed in the UK. It may be that a subset of tinnitus suffers can be managed though an e-learning treatment program, freeing up services for those with more severe problems that need face to face treatment.

Conditions
Tinnitus
Being tested
CBT-based internet-intervention for tinnitus
Keywords
tinnitus treatment, internet-intervention, CBT
Medical subject headings
Tinnitus, Color Vision Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-based internet-intervention for tinnitusBehavioural

    Also called iCBT

    The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.

Study groups in NCT02370810
Study groupRoleWhat they receive
experimental groupExperimentalCBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
Receives: Behavioral: CBT-based internet-intervention for tinnitus
weekly check-in group with delayed treatmentOtherwill complete weekly measures and commence the treatment once the experimental group completes the intervention
Receives: Behavioral: CBT-based internet-intervention for tinnitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Tinnitus Functional Index

    Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation TFI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

Secondary outcomes (8)

  1. Tinnitus Handicap Inventory-screening Version

    Measure of tinnitus severity to use as a weekly measure Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI-S Minimal value: 0 Maximum value 40 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  2. Insomnia Severity Index

    Measure of sleep problems Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  3. Cognitive Failures Questionnaire

    Measure of how cognitive difficulties such as concentration and memory Units of measurement: scores on a scale Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  4. Satisfaction With Life

    Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  5. Patient Health Questionnaire

    Measure of signs of depressive disorders Units of measurement: scores on a scale Minimal value: 0 Maximum value 28 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  6. Generalised Anxiety Disorder

    Measure of anxiety disorder and traits Units of measurement: scores on a scale Minimal value: 0 Maximum value 21 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  7. Hyperacusis Questionnaire

    Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

  8. Hearing Handicap Inventory- Screening Version

    Measure of hearing difficulties or hearing disability using a screening tool Units of measurement: scores on a scale Minimal value: 0 Maximum value 40 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

    Measured: Assessed at baseline and 8 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02370810
Sponsor's protocol ID
ARU-0115
Status last verified
Jun 2021
First submitted
3 Feb 2015
Last updated
14 Jul 2021
Data monitoring committee
Yes

Publications

  • Beukes E, Andersson G, Manchaiah V. Long-Term Outcomes of an Internet-Based Cognitive Behavior Therapy Intervention for Tinnitus: Follow-Up Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 May 1;152(5):503-512. doi: 10.1001/jamaoto.2026.0094.

    PubMed 41854598

  • Rodrigo H, Beukes EW, Andersson G, Manchaiah V. Internet-based cognitive-behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes. BMJ Open. 2021 Aug 20;11(8):e049384. doi: 10.1136/bmjopen-2021-049384.

    PubMed 34417217

  • Beukes EW, Baguley DM, Allen PM, Manchaiah V, Andersson G. Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Adults With Tinnitus in the United Kingdom: A Randomized Controlled Trial. Ear Hear. 2018 May/Jun;39(3):423-433. doi: 10.1097/AUD.0000000000000505.

    PubMed 29095725

  • Beukes EW, Manchaiah V, Allen PM, Baguley DM, Andersson G. Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial. BMJ Open. 2015 Sep 23;5(9):e008241. doi: 10.1136/bmjopen-2015-008241.

    PubMed 26399571

Questions about this trial

What is this clinical trial studying?

A study testing CBT-based internet-intervention for tinnitus in people with Tinnitus, run by Anglia Ruskin University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Tinnitus Functional Index (time frame: Assessed at baseline and 8 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02370810, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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