Clinical trial NCT02665975: Internet-based Versus Face-to-face Clinical Care for Tinnitus
Official title: Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus treatment
Internet-intervention
CBT
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The Tinnitus Functional Index
timeFrame: At baseline and at 8 weeks post-intervention
Secondary outcomes:
measure: Tinnitus Handicap Inventory
timeFrame: Assessed at baseline and 8 weeks post-intervention. Both time points are reported
measure: Satisfaction With Life Scale
timeFrame: Assessed at baseline and 8 weeks post-intervention. Both scores are reported
measure: Cognitive Failures Questionnaire
timeFrame: Assessed at baseline and 8 weeks post-intervention
measure: Patient Health Questionnaire
timeFrame: At baseline and at 8 weeks post-intervention
measure: Generalised Anxiety Disorder
timeFrame: At baseline and at 8 weeks post-intervention. Both scores are reported
measure: Hyperacusis Questionnaire
timeFrame: At baseline and at 8 weeks post-intervention. both scores are reported
measure: Hearing Handicap Inventory
timeFrame: At baseline and at 8 weeks post-intervention
measure: Insomnia Severity Index
timeFrame: Assessed at baseline and 8 weeks post-intervention. both scores are reported
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
Study officials:
affiliation: Anglia Ruskin University
name: Allen Peter
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.