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

NCT02370810 | Completed Results DMC

• 1 other identifier: ARU-0115
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

Tinnitus

Keywords

tinnitus treatment, internet-intervention, CBT

Outcome Measures

Primary Outcomes (1)

• The Tinnitus Functional Index

  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

  Assessed at baseline and 8 weeks post-intervention

Secondary Outcomes (8)

• Tinnitus Handicap Inventory-screening Version

  Assessed at baseline and 8 weeks post-intervention

• Insomnia Severity Index

  Assessed at baseline and 8 weeks post-intervention

• Cognitive Failures Questionnaire

  Assessed at baseline and 8 weeks post-intervention

• Satisfaction With Life

  Assessed at baseline and 8 weeks post-intervention

• Patient Health Questionnaire

  Assessed at baseline and 8 weeks post-intervention

Study Arms (2)

experimental group

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.

Behavioral: CBT-based internet-intervention for tinnitus

weekly check-in group with delayed treatment

OTHER

will complete weekly measures and commence the treatment once the experimental group completes the intervention

Behavioral: CBT-based internet-intervention for tinnitus

Interventions

CBT-based internet-intervention for tinnitus BEHAVIORAL

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.

Also known as: iCBT

experimental group; weekly check-in group with delayed treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant's eligibility for the study is as follows:
• Aged 18 years and over living in the UK
• 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
• Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire
• Suffering with tinnitus for a minimum period of 3 months
• Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index)

You may not qualify if:

• 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

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Linkoeping University: collaborator

Study Sites (1)

Vision and hearing Sciences, Anglia Ruskin Univeristy

Cambridge, CB1 1PT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 34417217 DERIVED

• Beukes EW, Baguley DM, Allen PM, Manchaiah V, Andersson G. Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Adults With Tinnitus in the United Kingdom: A Randomized Controlled Trial. Ear Hear. 2018 May/Jun;39(3):423-433. doi: 10.1097/AUD.0000000000000505.

  PMID: 29095725 DERIVED

• Beukes EW, Manchaiah V, Allen PM, Baguley DM, Andersson G. Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial. BMJ Open. 2015 Sep 23;5(9):e008241. doi: 10.1136/bmjopen-2015-008241.

  PMID: 26399571 DERIVED

MeSH Terms

Conditions

Tinnitus; Color Vision Defects

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases

Limitations and Caveats

Participants were recruited from the general public due to interest in undertaking an Internet-intervention and not from a clinical setting. The demographical distribution showed more male participants, a slightly higher mean age distribution and longer tinnitus duration than those reported by previous iCBT trials on tinnitus. Second, the likelihood of type I errors cannot be excluded due to multiplicity of testing. Third, not all participants completed the outcome measures

Results Point of Contact

• Title: Eldre Beukes
• Organization: Anglia Ruskin Univeristy

eldre.beukes@anglia.ac.uk

1223698847

Study Officials

• Peter Allen

  Anglia Ruskin University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs Eldre Wiida Beukes

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 25, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Locations

GB (1)