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A CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom

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: NCT02370810
Recruitment Status : Completed
First Posted : February 25, 2015
Results First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Eldre Beukes, Anglia Ruskin University

Study Description
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Brief Summary:
The purpose of this study is to determine the feasibility and effectiveness of a CBT-based internet intervention for adults with tinnitus in the United Kingdom

Condition or disease Intervention/treatment Phase
Tinnitus Behavioral: CBT-based internet-intervention for tinnitus 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 in Europe 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). It furthermore, aims to establish for which subgroups of tinnitus suffers this iCBT intervention would be a suitable intervention.

Design A two-armed Randomized Control Trial (RCT), with a one year follow-up design will be used to evaluate the effectiveness iCBT on tinnitus distress Setting: This will be an internet-based study for adults with tinnitus living in the UK

Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 70 participants will be recruited for each group and will be randomly assigned using a computer generated randomization schedule by an independent research assistant after being pre-stratified for age and tinnitus severity.

Intervention: 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.

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.

Hypothesis: If this intervention proves feasible it is and effective, 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
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
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.
Other Name: iCBT
weekly check-in group with delayed treatment
will complete weekly measures and commence the treatment once the experimental group completes the intervention
 Behavioral: 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.
Other Name: iCBT


Outcome Measures
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Primary Outcome Measures :
  1. The Tinnitus Functional Index [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    Measure of how severe the tinnitus is 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 used, not sub scales


Secondary Outcome Measures :
  1. Tinnitus Handicap Inventory-screening Version [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    Measure of tinnitus severity to use as a weekly measure Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI-S Minimal value: 0 Maximum value 40 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

  2. Insomnia Severity Index [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    Measure of sleep problems Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Units are scores on a scale 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. Satisfaction With Life [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome Units are scores on a scale Total score used, not sub scales

  5. Patient Health Questionnaire [ Time Frame: Assessed at baseline and 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 Units are scores on a scale Total score used, not sub scales

  6. Generalised Anxiety Disorder [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    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 Units are scores on a scale Total score used, not sub scales

  7. Hyperacusis Questionnaire [ Time Frame: Assessed at baseline and 8 weeks post-intervention ]
    Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales

  8. Hearing Handicap Inventory- Screening Version [ Time Frame: Assessed at baseline and 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 Units are scores on a scale Total score used, not sub scales


Eligibility Criteria
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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

Participant's eligibility for the study is as follows:

  1. Aged 18 years and over living in the UK
  2. The ability to read and type in English
  3. No barriers to using a computer (e.g. significant fine motor control or visual problems)
  4. Internet and e-mail access, and the ability to use these
  5. Commitment to completing the programme
  6. Completion of the online screening and outcome questionnaires
  7. Agreeing to participate in either group and be randomized to one of these groups
  8. 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
  9. Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire
  10. Suffering with tinnitus for a minimum period of 3 months
  11. Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index)

Exclusion Criteria

  1. Reporting any major medical or psychiatric conditions
  2. Reporting pulsatile, objective or unilateral tinnitus, which have not been investigated medically
  3. Tinnitus as a consequence of a medical disorder, still under investigation
  4. Undergoing any tinnitus therapy concurrently to partaking in this study
Contacts and Locations
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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): NCT02370810


Locations
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United Kingdom
Vision and hearing Sciences, Anglia Ruskin Univeristy
Cambridge, United Kingdom, CB1 1PT
Sponsors and Collaborators
Anglia Ruskin University
Linkoeping University
Investigators
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Study Chair: Peter Allen Anglia Ruskin University
  Study Documents (Full-Text)

Documents provided by Eldre Beukes, Anglia Ruskin University:
Study Protocol and Statistical Analysis Plan  [PDF] September 17, 2015
Informed Consent Form  [PDF] September 17, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eldre Beukes, Mrs Eldre Wiida Beukes, Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT02370810    
Other Study ID Numbers: ARU-0115
First Posted: February 25, 2015    Key Record Dates
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021
Last Verified: June 2021
Keywords provided by Eldre Beukes, 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