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Completed

NCT Number: NCT02370810

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

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

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Key information

Conditions

Tinnitus Color Vision Defects Cone Dystrophy Ear Diseases Eye Diseases Eye Diseases, Hereditary Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vision and hearing Sciences, Anglia Ruskin Univeristy

Cambridge, CB1 1PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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)

Exclusion criteria

  • 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

Treatment and study plan

CBT-based internet-intervention for tinnitus

Behavioral

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.

Other names: iCBT

Primary outcomes

  1. The Tinnitus Functional Index

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

Secondary outcomes

  1. Tinnitus Handicap Inventory-screening Version

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  2. Insomnia Severity Index

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  3. Cognitive Failures Questionnaire

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  4. Satisfaction With Life

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  5. Patient Health Questionnaire

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  6. Generalised Anxiety Disorder

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  7. Hyperacusis Questionnaire

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

  8. Hearing Handicap Inventory- Screening Version

    Time frame: Assessed at baseline and 8 weeks post-intervention

    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

Sponsors and collaborators

Lead sponsor

Anglia Ruskin University

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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