Internet-based Versus Face-to-face Clinical Care for Tinnitus

Not Applicable

Completed

Conditions: Tinnitus

Interventions: Behavioral: CBT-based internet-intervention for tinnitus
Behavioral: Face-to-face clinical tinnitus care

Registration Number: NCT02665975

Lead Sponsor: Anglia Ruskin University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group: iCBT	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.
Face-to-face clinical tinnitus care	Face-to-face clinical tinnitus care	Receive individual face-to-face tinnitus care, and follow-up appointments as required.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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

Trial Locations

Locations (3): Norfolk and Norwich University Hospital
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Norwich, Norfolk, United Kingdom
Hinchingbrooke Hospital
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Huntingdon, United Kingdom
Milton Keynes University Hospital
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Milton Keynes, United Kingdom