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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370810
• Other study ID #: ARU-0115
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2021
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

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.

Locations

Country	Name	City	State
United Kingdom	Vision and hearing Sciences, Anglia Ruskin Univeristy	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Anglia Ruskin University	Linkoeping University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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