Tinnitus
Conditions
Keywords
Tinnitus treatment, Internet-intervention, CBT
Brief summary
The purpose of this study is to compare the effectiveness of a CBT-based internet intervention with face to face standard clinical care 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 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) compared to standard face-to-face clinical care. Design A two-armed Randomized Control Trial (RCT), will be used to evaluate the effectiveness iCBT on tinnitus distress. Participants placed in the experimental group will receive iCBT and those in the control group will undergo standard face-to-face hospital based clinical care. Setting: This will be an multi-center study, recruiting from three tinnitus clinics in the East of England, UK; namely: Norfolk and Norwich University Hospital Trust, Milton Keynes University Hospital and Hinchingbrooke Healthcare NHS Trust Participants: Recruitment will be undertaken from 3 separate clinical settings. Adult patients seen by ENT Consultants or Audiologist at these centers who mention being significantly bothered by tinnitus, and who would normally be referred for tinnitus services will be considered for the study. 80 Participants will be recruited and will be randomly assigned to either receiving face-to-face clinical clinical care consisting or or internet-based intervention (iCBT). Intervention: i) iCBT group: This group will undergo 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. ii) Standard clinical care group: receive individual face-to-face tinnitus appointment providing the care deemed most important to this individual and follow-up appointments as required. 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. These will be measured at baseline, 3 months post- intervention and 6-months post- intervention, to assess the intervention effects over time. Hypothesis: If iCBT proves feasible and is effective compared to standard clinical care, 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
Tinnitus e-learning programme
BEHAVIORALFace-to-face clinical tinnitus care
Hospital tinnitus counselling
Sponsors
Anglia Ruskin University
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
* Attending either Norfolk and Norwich University Hospital, Milton Keynes University Hospital or Hinchingbrooke Hospitals as recruitment is via these hospitals * The ability to read and type in English * No barriers to using a computer (e.g. significant fine motor control or visual problems) * Internet and e-mail access, and the ability to use these * Commitment to completing the programme * Completion of the online screening and outcome questionnaires * Agreeing to participate in either group and be randomized to one of these groups * 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
Exclusion criteria
* Reporting any major medical or psychiatric conditions * Reporting pulsatile, objective or unilateral tinnitus, which have not been investigated medically * Tinnitus as a consequence of a medical disorder, still under investigation * Undergoing any tinnitus therapy concurrently to partaking in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Tinnitus Functional Index | At baseline and at 8 weeks post-intervention | A self-reported outcome measure of tinnitus severity. 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 out of 100 is reported and not any subscales Scores below 25 indicate mild tinnitus, from 25-50 indicated significant tinnitus and from 50-100 severe tinnitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Life Scale | Assessed at baseline and 8 weeks post-intervention. Both scores are reported | Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome 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 | At baseline and at 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 Total score used, not sub scales |
| Tinnitus Handicap Inventory | Assessed at baseline and 8 weeks post-intervention. Both time points are reported | Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Total score used, not sub scales |
| Hyperacusis Questionnaire | At baseline and at 8 weeks post-intervention. both scores are reported | Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Hotal score used, not sub scales |
| Hearing Handicap Inventory | At baseline and at 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 Total score used, not sub scales |
| Insomnia Severity Index | Assessed at baseline and 8 weeks post-intervention. both scores are reported | Measure of sleep problems Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Total score used, not sub scales |
| Generalised Anxiety Disorder | At baseline and at 8 weeks post-intervention. Both scores are reported | 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 Total score used, not sub scales |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group: iCBT 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: Tinnitus e-learning programme | 46 |
| Face-to-face Clinical Tinnitus Care Receive individual face-to-face tinnitus care, and follow-up appointments as required.
Face-to-face clinical tinnitus care: Hospital tinnitus counselling | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Total | Experimental Group: iCBT | Face-to-face Clinical Tinnitus Care |
|---|---|---|---|
| Age, Continuous | 52.96 years STANDARD_DEVIATION 12.07 | 50.65 years STANDARD_DEVIATION 12.19 | 55.26 years STANDARD_DEVIATION 11.62 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 37 Participants | 17 Participants | 20 Participants |
| Sex: Female, Male Male | 55 Participants | 29 Participants | 26 Participants |
| Tinnitus Functional Index Score at Baseline | 55.65 scores on a scale at baseline STANDARD_DEVIATION 21.01 | 55.01 scores on a scale at baseline STANDARD_DEVIATION 21.58 | 56.57 scores on a scale at baseline STANDARD_DEVIATION 20.61 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
The Tinnitus Functional Index
A self-reported outcome measure of tinnitus severity. 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 out of 100 is reported and not any subscales Scores below 25 indicate mild tinnitus, from 25-50 indicated significant tinnitus and from 50-100 severe tinnitus
Time frame: At baseline and at 8 weeks post-intervention
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | The Tinnitus Functional Index | 8 weeks post-intervention results | 22.85 score on a scale | Standard Deviation 19.26 |
| Experimental Group: iCBT | The Tinnitus Functional Index | Baseline results | 55.01 score on a scale | Standard Deviation 21.58 |
| Face-to-face Clinical Tinnitus Care | The Tinnitus Functional Index | 8 weeks post-intervention results | 32.51 score on a scale | Standard Deviation 23.28 |
| Face-to-face Clinical Tinnitus Care | The Tinnitus Functional Index | Baseline results | 55.26 score on a scale | Standard Deviation 11.62 |
Secondary
Cognitive Failures Questionnaire
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
Time frame: Assessed at baseline and 8 weeks post-intervention
Population: clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Cognitive Failures Questionnaire | 8 weeks post-intervention | 30.06 score on a scale | Standard Deviation 12.89 |
| Experimental Group: iCBT | Cognitive Failures Questionnaire | Baseline score | 34.93 score on a scale | Standard Deviation 14.38 |
| Face-to-face Clinical Tinnitus Care | Cognitive Failures Questionnaire | Baseline score | 39.65 score on a scale | Standard Deviation 19.31 |
| Face-to-face Clinical Tinnitus Care | Cognitive Failures Questionnaire | 8 weeks post-intervention | 33.06 score on a scale | Standard Deviation 19.24 |
Secondary
Generalised Anxiety Disorder
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 Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention. Both scores are reported
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Generalised Anxiety Disorder | 8 weeks post-intervention | 3.33 score on a scale | Standard Deviation 3.21 |
| Experimental Group: iCBT | Generalised Anxiety Disorder | baseline scores | 6.43 score on a scale | Standard Deviation 5.64 |
| Face-to-face Clinical Tinnitus Care | Generalised Anxiety Disorder | 8 weeks post-intervention | 3.42 score on a scale | Standard Deviation 3.6 |
| Face-to-face Clinical Tinnitus Care | Generalised Anxiety Disorder | baseline scores | 6.78 score on a scale | Standard Deviation 5.54 |
Secondary
Hearing Handicap Inventory
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 Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Hearing Handicap Inventory | 8 weeks post-intervention | 9.11 score on a scale | Standard Error 11.59 |
| Experimental Group: iCBT | Hearing Handicap Inventory | Baseline score | 11.74 score on a scale | Standard Error 10.66 |
| Face-to-face Clinical Tinnitus Care | Hearing Handicap Inventory | 8 weeks post-intervention | 12.00 score on a scale | Standard Error 9.56 |
| Face-to-face Clinical Tinnitus Care | Hearing Handicap Inventory | Baseline score | 14.3 score on a scale | Standard Error 11.58 |
Secondary
Hyperacusis Questionnaire
Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Hotal score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention. both scores are reported
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Hyperacusis Questionnaire | 8 weeks post-intervention | 12.51 score on a scale | Standard Deviation 9.01 |
| Experimental Group: iCBT | Hyperacusis Questionnaire | Baseline severity | 15.65 score on a scale | Standard Deviation 9.06 |
| Face-to-face Clinical Tinnitus Care | Hyperacusis Questionnaire | 8 weeks post-intervention | 12.94 score on a scale | Standard Deviation 7.51 |
| Face-to-face Clinical Tinnitus Care | Hyperacusis Questionnaire | Baseline severity | 15.65 score on a scale | Standard Deviation 7.42 |
Secondary
Insomnia Severity Index
Measure of sleep problems Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. both scores are reported
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Insomnia Severity Index | 8 weeks post-intervention | 5.69 score on a scale | Standard Deviation 4.64 |
| Experimental Group: iCBT | Insomnia Severity Index | Baseline score | 11.43 score on a scale | Standard Deviation 6.36 |
| Face-to-face Clinical Tinnitus Care | Insomnia Severity Index | 8 weeks post-intervention | 10.03 score on a scale | Standard Deviation 6.88 |
| Face-to-face Clinical Tinnitus Care | Insomnia Severity Index | Baseline score | 13.65 score on a scale | Standard Deviation 6.62 |
Secondary
Patient Health Questionnaire
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 Total score used, not sub scales
Time frame: At baseline and at 8 weeks post-intervention
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Patient Health Questionnaire | 8 weeks post-intervention | 2.78 score on a scale | Standard Deviation 3.02 |
| Experimental Group: iCBT | Patient Health Questionnaire | Baseline score | 6.5 score on a scale | Standard Deviation 5.48 |
| Face-to-face Clinical Tinnitus Care | Patient Health Questionnaire | 8 weeks post-intervention | 4.97 score on a scale | Standard Deviation 4.54 |
| Face-to-face Clinical Tinnitus Care | Patient Health Questionnaire | Baseline score | 7.98 score on a scale | Standard Deviation 6.05 |
Secondary
Satisfaction With Life Scale
Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. Both scores are reported
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Satisfaction With Life Scale | 8 weeks post-intervention socre | 21.00 score on a scale | Standard Deviation 5.05 |
| Experimental Group: iCBT | Satisfaction With Life Scale | Baseline Score | 18.7 score on a scale | Standard Deviation 5.73 |
| Face-to-face Clinical Tinnitus Care | Satisfaction With Life Scale | 8 weeks post-intervention socre | 20.50 score on a scale | Standard Deviation 4.95 |
| Face-to-face Clinical Tinnitus Care | Satisfaction With Life Scale | Baseline Score | 19.48 score on a scale | Standard Deviation 5.54 |
Secondary
Tinnitus Handicap Inventory
Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Total score used, not sub scales
Time frame: Assessed at baseline and 8 weeks post-intervention. Both time points are reported
Population: Clinical population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: iCBT | Tinnitus Handicap Inventory | 8 weeks post-intervention scores | 17.78 score on a scale | Standard Deviation 14.77 |
| Experimental Group: iCBT | Tinnitus Handicap Inventory | Baseline scores | 44.57 score on a scale | Standard Deviation 23.4 |
| Face-to-face Clinical Tinnitus Care | Tinnitus Handicap Inventory | 8 weeks post-intervention scores | 27.11 score on a scale | Standard Deviation 21.62 |
| Face-to-face Clinical Tinnitus Care | Tinnitus Handicap Inventory | Baseline scores | 47.13 score on a scale | Standard Deviation 20.31 |