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

Tinnitus Clinical Trial

Official title:

Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665975
• Other study ID #: ARU-0116
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• CBT-based internet-intervention for tinnitus
Tinnitus e-learning programme
• Face-to-face clinical tinnitus care
Hospital tinnitus counselling

Locations

Country	Name	City	State
United Kingdom	Hinchingbrooke Hospital	Huntingdon
United Kingdom	Milton Keynes University Hospital	Milton Keynes
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Assessed at baseline and 8 weeks post-intervention. Both time points are reported
Secondary	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	Assessed at baseline and 8 weeks post-intervention. Both scores are reported
Secondary	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	Assessed at baseline and 8 weeks post-intervention
Secondary	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	At baseline and at 8 weeks post-intervention
Secondary	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	At baseline and at 8 weeks post-intervention. Both scores are reported
Secondary	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	At baseline and at 8 weeks post-intervention. both scores are reported
Secondary	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	At baseline and at 8 weeks post-intervention
Secondary	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	Assessed at baseline and 8 weeks post-intervention. both scores are reported