Evidence map›Paper›PMID 28431551›Full record

Trial reportTrials2017

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

Eldré W Beukes, David M Baguley, Peter M Allen, Vinaya Manchaiah, Gerhard Andersson

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02665975 (Internet-based Versus Face-to-face Clinical Care for Tinnitus), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02665975 nacompletednot on this map

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

TypeinterventionalSponsorAnglia Ruskin UniversityRan2016 to 2017Enrolled92ConditionsTinnitusArmsCBT-based internet-intervention for tinnitus, Face-to-face clinical tinnitus care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Eldré W BeukesDepartment of Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK. eldre.beukes@anglia.ac.uk.
David M BaguleyDepartment of Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK.
Peter M AllenDepartment of Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK.
Vinaya ManchaiahDepartment of Speech and Hearing Sciences, Lamar University, Beaumont, Texas, USA.
Gerhard AnderssonDepartment of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.

Funding

MRF_ MRF-049-0002-RG-BSAUD
6 · The paper itself

Abstract

backgroundInnovative 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/

designThis 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 registrationClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Indexed as

InternetClinical ProtocolsCognitive Behavioral TherapyDisability EvaluationEnglandHumansResearch DesignSeverity of Illness IndexSurveys and QuestionnairesTherapy, Computer-AssistedTime FactorsTinnitusTreatment OutcomeClinical interventionCognitive behavioural therapyGuided interventionInternet interventionNon-inferiority trialService developmentTinnitus distressTinnitus managementTinnitus treatment

Identifiers

PMID28431551
PMCPMC5399814

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.