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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665975
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tinnitus Behavioral: CBT-based internet-intervention for tinnitus Behavioral: Face-to-face clinical tinnitus care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: 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.
Behavioral: CBT-based internet-intervention for tinnitus
Tinnitus e-learning programme
Other Name: iCBT

Active Comparator: Face-to-face clinical tinnitus care
Receive individual face-to-face tinnitus care, and follow-up appointments as required.
Behavioral: Face-to-face clinical tinnitus care
Hospital tinnitus counselling




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Tinnitus Handicap Inventory [ Time Frame: 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

  2. Satisfaction With Life Scale [ Time Frame: 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


  3. Cognitive Failures Questionnaire [ Time Frame: 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

  4. Patient Health Questionnaire [ Time Frame: 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

  5. Generalised Anxiety Disorder [ Time Frame: 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

  6. Hyperacusis Questionnaire [ Time Frame: 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

  7. Hearing Handicap Inventory [ Time Frame: 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

  8. Insomnia Severity Index [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665975


Locations
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United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Hinchingbrooke Hospital
Huntingdon, United Kingdom, PE29 6NT
Milton Keynes University Hospital
Milton Keynes, United Kingdom, MK6 5LD
Sponsors and Collaborators
Anglia Ruskin University
Investigators
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Study Chair: Allen Peter Anglia Ruskin University
  Study Documents (Full-Text)

Documents provided by Anglia Ruskin University:
Informed Consent Form  [PDF] May 31, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT02665975    
Other Study ID Numbers: ARU-0116
First Posted: January 28, 2016    Key Record Dates
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anglia Ruskin University:
Tinnitus treatment
Internet-intervention
CBT
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases