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

NCT02665975 | Completed Results DMC

• 1 other identifier: ARU-0116
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 3

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.

Conditions

Tinnitus

Keywords

Tinnitus treatment; Internet-intervention; CBT

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline and at 8 weeks post-intervention

Secondary Outcomes (8)

• Tinnitus Handicap Inventory

  Assessed at baseline and 8 weeks post-intervention. Both time points are reported

• Satisfaction With Life Scale

  Assessed at baseline and 8 weeks post-intervention. Both scores are reported

• Cognitive Failures Questionnaire

  Assessed at baseline and 8 weeks post-intervention

• Patient Health Questionnaire

  At baseline and at 8 weeks post-intervention

• Generalised Anxiety Disorder

  At baseline and at 8 weeks post-intervention. Both scores are reported

Study Arms (2)

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.

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.

Behavioral: Face-to-face clinical tinnitus care

Interventions

CBT-based internet-intervention for tinnitus BEHAVIORAL

Tinnitus e-learning programme

Also known as: iCBT

Experimental group: iCBT

Face-to-face clinical tinnitus care BEHAVIORAL

Hospital tinnitus counselling

Face-to-face clinical tinnitus care

Eligibility Criteria

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

You may qualify if:

• 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

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

Study Sites (3)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Hinchingbrooke Hospital

Huntingdon, PE29 6NT, United Kingdom

Location

Milton Keynes University Hospital

Milton Keynes, MK6 5LD, 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, 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.

  PMID: 30286238 DERIVED

• Beukes 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.

  PMID: 28431551 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial had many challenges, such as difficulty recruiting a sufficient number of participants. The low ratio of people participating in the study in comparison with those who were invited was a potential source of bias. In addition, the nonuniform nature of the clinical care received from the various study centers may have contributed to the variability. Interpretation of the data are limited to participants with similar demographic and clinical profiles.

Results Point of Contact

• Title: Eldre Beukes
• Organization: Anglia Ruskin Univeristy

eldre.beukes@anglia.ac.uk

01223698847

Study Officials

• Allen Peter

  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: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 28, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)