TinnitusNCT02665975
Internet-based Versus Face-to-face Clinical Care for Tinnitus
A study testing CBT-based internet-intervention for tinnitus and Face-to-face clinical tinnitus care in people with Tinnitus, run by Anglia Ruskin University at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- CBT-based internet-intervention for tinnitus and Face-to-face clinical tinnitus care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hinchingbrooke Hospital
Huntingdon, PE29 6NT
Milton Keynes University Hospital
Milton Keynes, MK6 5LD
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
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.
Read the 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:
- 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.
- Conditions
- Tinnitus
- Being tested
- CBT-based internet-intervention for tinnitus, Face-to-face clinical tinnitus care
- Keywords
- Tinnitus treatment, Internet-intervention, CBT
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based internet-intervention for tinnitusBehavioural
Also called iCBT
Tinnitus e-learning programme
Face-to-face clinical tinnitus careBehavioural
Hospital tinnitus counselling
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: iCBT | Experimental | 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. Receives: Behavioral: CBT-based internet-intervention for tinnitus |
| Face-to-face clinical tinnitus care | Active comparator | Receive individual face-to-face tinnitus care, and follow-up appointments as required. Receives: Behavioral: Face-to-face clinical tinnitus care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and at 8 weeks post-intervention
Secondary outcomes (8)
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
Measured: Assessed at baseline and 8 weeks post-intervention. Both time points are reported
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
Measured: Assessed at baseline and 8 weeks post-intervention. Both scores are reported
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
Measured: Assessed at baseline and 8 weeks post-intervention
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
Measured: At baseline and at 8 weeks post-intervention
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
Measured: At baseline and at 8 weeks post-intervention. Both scores are reported
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
Measured: At baseline and at 8 weeks post-intervention. both scores are reported
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
Measured: At baseline and at 8 weeks post-intervention
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
Measured: Assessed at baseline and 8 weeks post-intervention. both scores are reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen Peter, Study chair, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665975
- Sponsor's protocol ID
- ARU-0116
- Status last verified
- Jul 2019
- First submitted
- 22 Jan 2016
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rodrigo H, Beukes EW, Andersson G, Manchaiah V. Internet-based cognitive-behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes. BMJ Open. 2021 Aug 20;11(8):e049384. doi: 10.1136/bmjopen-2021-049384.
PubMed 34417217Beukes EW, Andersson G, Allen PM, Manchaiah V, Baguley DM. Effectiveness of Guided Internet-Based Cognitive Behavioral Therapy vs Face-to-Face Clinical Care for Treatment of Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1126-1133. doi: 10.1001/jamaoto.2018.2238.
PubMed 30286238Beukes EW, Baguley DM, Allen PM, Manchaiah V, Andersson G. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. Trials. 2017 Apr 21;18(1):186. doi: 10.1186/s13063-017-1931-6.
PubMed 28431551
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02665975
- Acronym / sponsor ID
- ARU-0116
- Conditions
- Tinnitus
- Keywords
- Tinnitus treatment, Internet-intervention, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: iCBT | Experimental | Behavioral: CBT-based internet-intervention for tinnitusCBT-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 | Active comparator | Behavioral: Face-to-face clinical tinnitus careReceive individual face-to-face tinnitus care, and follow-up appointments as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-based internet-intervention for tinnitusAlso: iCBTTinnitus e-learning programme | Behavioural | Experimental group: iCBT |
| Face-to-face clinical tinnitus careHospital tinnitus counselling | Behavioural | Face-to-face clinical tinnitus care |
Primary outcome
The Tinnitus Functional Index
Time frame: 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
8 secondary outcomes
Tinnitus Handicap Inventory
Time frame: Assessed at baseline and 8 weeks post-intervention. Both time points are reported
Satisfaction With Life Scale
Time frame: Assessed at baseline and 8 weeks post-intervention. Both scores are reported
Cognitive Failures Questionnaire
Time frame: Assessed at baseline and 8 weeks post-intervention
Patient Health Questionnaire
Time frame: At baseline and at 8 weeks post-intervention
Generalised Anxiety Disorder
Time frame: At baseline and at 8 weeks post-intervention. Both scores are reported
Hyperacusis Questionnaire
Time frame: At baseline and at 8 weeks post-intervention. both scores are reported
Hearing Handicap Inventory
Time frame: At baseline and at 8 weeks post-intervention
Insomnia Severity Index
Time frame: Assessed at baseline and 8 weeks post-intervention. both scores are reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34417217Rodrigo H, Beukes EW, Andersson G, Manchaiah V. Internet-based cognitive-behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes. BMJ Open. 2021 Aug 20;11(8):e049384. doi: 10.1136/bmjopen-2021-049384.
- Derived from this study: PubMed 30286238Beukes EW, Andersson G, Allen PM, Manchaiah V, Baguley DM. Effectiveness of Guided Internet-Based Cognitive Behavioral Therapy vs Face-to-Face Clinical Care for Treatment of Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1126-1133. doi: 10.1001/jamaoto.2018.2238.
- Derived from this study: PubMed 28431551Beukes EW, Baguley DM, Allen PM, Manchaiah V, Andersson G. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. Trials. 2017 Apr 21;18(1):186. doi: 10.1186/s13063-017-1931-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Peter study chair
Anglia Ruskin University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based internet-intervention for tinnitus and Face-to-face clinical tinnitus care in people with Tinnitus, run by Anglia Ruskin University at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Tinnitus Functional Index (time frame: At baseline and at 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665975, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.