Dataset Information

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

ABSTRACT: BACKGROUND:Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. POPULATION:Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. METHODS/DESIGN:This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. DISCUSSION:This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

SUBMITTER: Beukes EW

PROVIDER: S-EPMC5399814 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

Beukes Eldré W EW Baguley David M DM Allen Peter M PM Manchaiah Vinaya V Andersson Gerhard G

Trials 20170421 1

<h4>Background</h4>Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K.<h4>Population</h4>Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an ...[more]

PMID: 28431551

Similar Datasets

Project description:ImportanceAccessible clinical care is not always available to individuals with distressing tinnitus. Internet-based cognitive behavioral therapy has the potential to increase access to evidence-based services that manage tinnitus. Research comparing the effectiveness of this internet-based intervention with face-to-face care is required.ObjectiveTo evaluate whether an internet-based cognitive behavioral therapy intervention is at least as effective as established individualized face-to-face clinical care in reducing tinnitus distress and tinnitus-related difficulties.Design, setting, and participantsA randomized, multicenter, 2-arm parallel group, noninferiority trial with 2-month follow-up was performed between October 4, 2016, and July 14, 2017. Invited to participate were 374 adults based in the United Kingdom who had been referred to their local tinnitus clinics because of bothersome tinnitus. The experimental group received the internet-based intervention online, and the active control group underwent the usual face-to-face tinnitus care at 1 of 3 UK-based National Health Service hospitals. Participants were randomly assigned (1:1) to either intervention using variable permuted block sizes of 4 and 6. Of 92 participants who were randomized (46 each in the experimental and control groups), 88 participants completed the assessment immediately after intervention and 74 participants completed the follow-up assessment.InterventionsParticipants were randomized to receive either 8 weeks of guided internet-based cognitive behavioral therapy or a mean of 2 to 3 individualized face-to-face appointments in a tinnitus clinic.Main outcomes and measuresThe primary outcome was a change in tinnitus distress (assessed by the Tinnitus Functional Index). Secondary assessment measures were included for insomnia, anxiety, depression, hearing disability, hyperacusis, cognitive failures, and satisfaction with life.ResultsOf 92 patients overall, 55 (60%) were men with a mean (SD) age of 52.96 (12.07) years and mean (SD) tinnitus duration of 6.54 (9.25) years. The between-group difference in the Tinnitus Functional Index scores after intervention were 5.18 (95% CI, -4.17 to 14.53) at the initial assessment and 5.52 (95% CI, -4.60 to 15.61) at follow-up; both differences were within the noninferiority margin of 13 points for the lower 95% CI. For the secondary outcomes, only outcomes for insomnia fell outside the noninferiority margin, both after intervention and at follow-up, favoring internet-based cognitive behavioral therapy.Conclusions and relevanceThis is the first trial, to our knowledge, to compare an internet-based intervention with standard individualized face-to-face care for tinnitus. It revealed that both interventions are equally effective for reducing tinnitus distress and most tinnitus-related difficulties.Trial registrationClinicalTrials.gov identifier: NCT02665975.

Project description:IntroductionExpert guidelines recommend cognitive-behavioural therapy (CBT) as a first-line treatment for obsessive-compulsive disorder (OCD), but the majority of patients with OCD do not have access to CBT. Internet-delivered CBT (ICBT) has the potential to make this evidence-based treatment more accessible while requiring less therapist time than traditional face-to-face (f2f) CBT. Data from six clinical trials suggest that ICBT for OCD is both efficacious and cost-effective, but whether ICBT is non-inferior to traditional f2f CBT for OCD is yet unknown.Methods and analysisA single-blind, randomised, controlled, non-inferiority trial comparing therapist-guided ICBT, unguided ICBT and individual (f2f) CBT for adult OCD patients. The primary objective is to investigate whether ICBT is non-inferior to gold standard f2f CBT. Secondary objectives are to investigate if ICBT is equally effective when delivered unguided, to establish the cost-effectiveness of ICBT and to investigate if the treatment outcome differs between self-referred and clinically referred patients. Participants will be recruited at two specialist OCD clinics in Stockholm and also through online self-referral. Participants will be randomised to one of three treatment conditions: F2f CBT, ICBT with therapist support or unguided ICBT. The total number of participants will be 120, and masked assessments will be administered at baseline, biweekly during treatment, at post-treatment and at 3-month and 12-month follow-ups. The main outcome measure is the clinician-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 3-month follow-up. The margin of non-inferiority is set to 3 points on the Y-BOCS using a 90% CI.Ethics and disseminationThe study has been approved by the Regional Ethics Board of Stockholm (REPN 2015/1099-31/2) and registered at Clinicaltrials.gov (NCT02541968). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.Trial registration numberNCT02541968; Pre-results.

Dataset Information

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

Publications

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets