Overview

This trial is active, not recruiting.

Condition tinnitus
Treatment cbt-based internet-intervention for tinnitus
Sponsor Anglia Ruskin University
Collaborator Linkoeping University
Start date October 2015
End date January 2017
Trial size 160 participants
Trial identifier NCT02370810, ARU-0115

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cbt-based internet-intervention for tinnitus iCBT
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.
(No Intervention)
will complete weekly measures and commence the treatment once the experimental group completes the intervention

Primary Outcomes

Measure
The Tinnitus Functional Index
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment

Secondary Outcomes

Measure
Tinnitus Handicap Inventory-screening version
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Insomnia Severity Index
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Cognitive Failures Questionnaire
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Satisfaction with Life
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Patient Health Questionnaire
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Generalised Anxiety Disorder
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Hyperacusis Questionnaire
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment
Hearing Handicap Inventory- screening version
time frame: At baseline, at 8 weeks, 16 weeks anad 12 months post treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study Protocol for a CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Anglia Ruskin University.