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

Anglia Ruskin University

Status: Completed

Conditions: Tinnitus

Treatments: Behavioral: CBT-based internet-intervention for tinnitus

Study type: Interventional

Funder types: Other

Identifiers

NCT02370810

ARU-0115

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: CBT-based internet-intervention for tinnitus

weekly check-in group with delayed treatment

Other group

Description:

will complete weekly measures and commence the treatment once the experimental group completes the intervention

Treatment:

Behavioral: CBT-based internet-intervention for tinnitus