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

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

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Behavioral: CBT-based internet-intervention for tinnitus

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB1 1PT
    • Vision and hearing Sciences, Anglia Ruskin Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Participant's eligibility for the study is as follows:

1. Aged 18 years and over living in the UK
2. The ability to read and type in English
3. No barriers to using a computer (e.g. significant fine motor control or visual problems)
4. Internet and e-mail access, and the ability to use these
5. Commitment to completing the programme
6. Completion of the online screening and outcome questionnaires
7. Agreeing to participate in either group and be randomized to one of these groups
8. 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
9. Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire
10. Suffering with tinnitus for a minimum period of 3 months
11. Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index)

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; CBT-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.	Behavioral: CBT-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.; Other Names: iCBT
Other: weekly check-in group with delayed treatment; will complete weekly measures and commence the treatment once the experimental group completes the intervention	Behavioral: CBT-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.; Other Names: iCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at baseline and 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention
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	Assessed at baseline and 8 weeks post-intervention

Collaborators and Investigators

• Sponsor: Anglia Ruskin University
• Collaborators: Linkoeping University
• Investigators: Study Chair: Peter Allen, Anglia Ruskin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: tinnitus treatment, internet-intervention, CBT
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: ARU-0115