Background
Methods/design
Study objectives
Study design
Study population
Recruitment
Inclusion criteria
Exclusion criteria
Enrolment and randomisation
Withdrawal/discontinuation of participants
Assessment measures
Study period | Enrolment | Intervention | Post-intervention | Follow-up |
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Measurement time point | T0 (baseline) | Lasting 2 months on average | T1 (2–3 months after baseline) | T2 (2 months post- intervention) |
Enrolment | ||||
Informed consent | X | |||
Online screening questionnaire | X | |||
Telephone screening | X | |||
Intervention allocation | X | |||
Assessments | ||||
Tinnitus Functional Index | X | X | X | |
Tinnitus Handicap Inventory | X | X | X | |
Insomnia Severity Index | X | X | X | |
Patient Health Questionnaire | X | X | X | |
Generalised Anxiety Disorder | X | X | X | |
Hyperacusis Questionnaire | X | X | X | |
Hearing Handicap Inventory | X | X | X | |
Cognitive Failures Questionnaire | X | X | X | |
Satisfaction with Life Scale | X | X | X | |
Tinnitus Handicap Inventory-Screening Version | Weekly for 8 weeks | |||
Post-intervention telephone call | X |
Primary assessment measure
Secondary assessment measures
Weekly assessment measure
Assessment measurement schedule
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Pre-intervention baseline measurements (T 0 ): Baseline measurements will be collected following study registration and prior to allocation.
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Weekly assessment measurements (during intervention): Whilst in the intervention phase, both groups will be monitored for an 8-week period by means of the THI-s. Participants from both groups will be in active intervention for an average duration of 2 months, although there may be some individual variation from this. Those allocated to the iCBT experimental group will start the iCBT intervention following allocation. Those in the active F2F control arm will commence hospital-based intervention in the first available clinical opening, typically 1–4 weeks post-allocation.
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Post-intervention measurements (T 1 ): Data will be collected post-intervention, typically 2–3 months following baseline data collection. The same assessment measures administered at baseline will be completed.
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Follow-up intervention measurements (T 2 ): Follow-up data will be collected 2 months post-intervention to determine the stability of intervention effects at this time point.
Semi-structured interviews
Study interventions
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The experimental iCBT group, which will receive the iCBT intervention over an 8-week period
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The F2F active control group, which will be under the care of their local hospital for an average duration of 8 weeks and attend an average of two or three appointments
Intervention outline for both groups
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The estimated duration of active intervention is an 8-week period for both groups, although some individual variation may occur.
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Information about managing tinnitus will be provided to both groups. The delivery of this information will differ, however, being provided online for the iCBT group and F2F for the active F2F control group.
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A log will be kept of the information provided to individuals in both groups. This will be the modules actually done by the iCBT group participants and content covered during appointments for individuals in the F2F group.
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During the initial clinical examination, all participants will be assessed regarding their suitability for hearing aids or combination devices. Where indicated, these will be provided regardless of group allocation.
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An audiologically trained professional will support both groups. This may be a hearing therapist, audiologist or clinical scientist in audiology. Criteria for inclusion of clinicians (providing the intervention to both groups) will be to have had training and experience in managing patients with tinnitus, to be part of a professional tinnitus network and to maintain good clinical practice. In this way, the interventions provided were standardised as much as possible despite participants’ attending different hospitals. The clinicians also agreed to abide by a structured protocol in order for similar components to be received by all participants.
Guided iCBT intervention outline (experimental group)
Time line | Intervention content | Intervention load | |
---|---|---|---|
Weekly reading | Daily practising | ||
Week 1 | Programme rational and outline | 15 minutes | |
Understanding tinnitus | 15 minutes | ||
Week 2 | Deep relaxation | 10 minutes | 10 minutes |
Positive imagery | 10 minutes | 5 minutes | |
Sound enrichmenta
| 10 minutes | As required | |
Week 3 | Diaphragmatic breathing | 10 minutes | 10 minutes |
Reinterpreting tinnitus | 10 minutes | 5 minutes | |
Sleep managementa
| 15 minutes | As required | |
Week 4 | Entire body relaxation | 10 minutes | 5 minutes |
Focussing techniques | 10 minutes | 5 minutes | |
Concentration managementa
| 10 minutes | As required | |
Week 5 | Rapid relaxation | 10 minutes | 3 minutes |
Thought analysis | 15 minutes | 3 × 15 minutes | |
Reducing sound sensitivitya
| 15 minutes | Daily | |
Week 6 | Relaxation in daily routines | 10 minutes | 3–5 situations |
Cognitive restructuring | 15 minutes | 3 × 15 minutes | |
Communication tacticsa
| 15 minutes | As required | |
Week 7 | Relaxation in stressful situations | 10 minutes | As required |
Exposure to tinnitus | 10 minutes | 3 × 5 minutes | |
Week 8 | Reviewing helpful techniques | 20 minutes | Evaluation |
Maintenance and relapse prevention | 20 minutes | Future plan |
Timeline | Intervention content to be individually tailored and may include | Intervention load | |
---|---|---|---|
Explanation | Daily practising | ||
Initial appointment | In-depth case history | 20 minutes | |
Information about tinnitus | 20 minutes | ||
Sound enrichment advice and equipment demonstration | 20 minutes | As required | |
Follow-up appointment | Recap | 5 minutes | |
Relaxation advice | 15 minutes | 10 minutes | |
Sleep management advice | 20 minutes | As required | |
CBT techniques such as identifying negative automatic thoughts | 20 minutes | As required | |
Second follow-up appointment | Review difficulties and address these | 20 minutes | As required |
Advice on further support (e.g., tinnitus support groups, charities, tinnitus apps) | 20 minutes | As required | |
Further options (e.g., mindfulness, hypnosis or concentration management) | 20 minutes | As required |