Clinical trial NCT02370810: A CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom
Official title: CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus treatment, internet-intervention, CBT
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2015-02-25
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility 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

Primary outcomes:
measure: The Tinnitus Functional Index
timeFrame: Assessed at baseline and 8 weeks post-intervention
Secondary outcomes:
measure: Tinnitus Handicap Inventory-screening Version
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Insomnia Severity Index
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Cognitive Failures Questionnaire
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Satisfaction With Life
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Patient Health Questionnaire
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Generalised Anxiety Disorder
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Hyperacusis Questionnaire
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Hearing Handicap Inventory- Screening Version
timeFrame: Assessed at baseline and 8 weeks post-intervention
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Vision and hearing Sciences, Anglia Ruskin Univeristy
Study officials:
affiliation: Anglia Ruskin University
name: Peter Allen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.