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

Not Applicable

Completed

Conditions: Tinnitus

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

Registration Number: NCT02370810

Lead Sponsor: Anglia Ruskin University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	CBT-based internet-intervention for tinnitus	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.
weekly check-in group with delayed treatment	CBT-based internet-intervention for tinnitus	will complete weekly measures and commence the treatment once the experimental group completes the intervention

Primary Outcome Measures

Name	Time	Method
The Tinnitus Functional Index	Assessed at baseline and 8 weeks post-intervention	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

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Assessed at baseline and 8 weeks post-intervention	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
Satisfaction With Life	Assessed at baseline and 8 weeks post-intervention	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
Tinnitus Handicap Inventory-screening Version	Assessed at baseline and 8 weeks post-intervention	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
Cognitive Failures Questionnaire	Assessed at baseline and 8 weeks post-intervention	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
Patient Health Questionnaire	Assessed at baseline and 8 weeks post-intervention	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
Generalised Anxiety Disorder	Assessed at baseline and 8 weeks post-intervention	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
Hyperacusis Questionnaire	Assessed at baseline and 8 weeks post-intervention	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
Hearing Handicap Inventory- Screening Version	Assessed at baseline and 8 weeks post-intervention	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