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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02370810

Enrollment

146

Registered

2015-02-25

Start date

2016-01-31

Completion date

2017-09-30

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

tinnitus treatment, internet-intervention, CBT

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.

Interventions

BEHAVIORALCBT-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
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
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

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Experimental Group 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: 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.	73
Weekly check-in Group will complete weekly measures and commence the treatment once the experimental group completes the intervention	73
Total	146

Baseline characteristics

Characteristic	Total	Experimental Group	Weekly check-in Group
Age, Continuous	55.57 years STANDARD_DEVIATION 12.86	56.82 years STANDARD_DEVIATION 12.15	54.31 years STANDARD_DEVIATION 13.5
Race and Ethnicity Not Collected	0 Participants	—	—
Sex: Female, Male Female	70 Participants	30 Participants	40 Participants
Sex: Female, Male Male	76 Participants	43 Participants	33 Participants
Tinnitus Severity at baseline	59.5 Score on a scale (0-100) STANDARD_DEVIATION 18.4	59.8 Score on a scale (0-100) STANDARD_DEVIATION 18	59.2 Score on a scale (0-100) STANDARD_DEVIATION 19

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 73	0 / 73
other Total, other adverse events	0 / 73	0 / 73
serious Total, serious adverse events	0 / 73	0 / 73

Outcome results

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