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

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.DiscussionThis 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1931-6) contains supplementary material, which is available to authorized users.

Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Adults With Tinnitus in the United Kingdom: A Randomized Controlled Trial

“…The small improvement found in the control group (5 points) at T1 may have been related to the positive effects of being included on an intervention pathway, despite not yet starting the intervention. The mean score reduction of 21 between T0-T1 in the experimental group in the present study is comparable to the findings in the initial feasibility study with a mean difference of 19 points (Beukes et al 2017). The TFI score improvements found in the experimental group were greater than those occurring in the control group.…”

Methodological Aspects of Randomized Controlled Trials for Tinnitus: A Systematic Review and How a Decision Support System Could Overcome Barriers

“…Primary objective of the included RCTs is the evaluation of specific therapeutic approaches; seventeen of them focus on transcranial magnetic stimulation (TMS) [ 28 , 33 , 41 , 42 , 44 , 45 , 48 , 54 , 67 , 71 , 72 , 76 , 79 , 82 , 85 , 89 , 90 , 91 ], four on acupuncture as monotherapy [ 25 , 51 , 53 , 66 ], more than ten on cognitive behavioral treatment, relaxation and mindfulness [ 20 , 21 , 23 , 26 , 35 , 40 , 47 , 61 , 65 , 68 , 69 , 70 , 75 , 81 , 92 ], seven on provision of hearing aids [ 38 , 41 , 63 , 84 , 87 , 93 , 94 ], 8 on sound therapy [ 24 , 39 , 55 , 60 , 86 , 95 , 96 , 97 ], two on electrical stimulation [ 29 , …”

Internet-delivered cognitive behavioral therapy for tinnitus compared to Internet-delivered mindfulness for tinnitus: a study protocol of a randomized controlled trial

“…The ICBT is based on a self-help program created by Andersson and colleagues and is designed to address the physical, emotional, and problematic effects of tinnitus for habituation [ 35 ]. The program includes key audiological principles and has been modified previously to an interactive e-learning format for better engagement [ 10 ]. The 16 recommended modules and 5 optional modules can be tailored to individual needs and are released weekly over an 8-week period.…”

“…Some specific maladaptive psychological coping like avoidance and non-acceptance and negative cognitions about tinnitus has been suggested to be possible mechanisms of increased suffering from bothersome tinnitus [ 6 – 9 ]. Untreated bothersome tinnitus can significantly reduce the quality of life and may affect many other daily life aspects like sleep, concentration, and mental health [ 10 ]. Fortunately, psychological interventions can be effective in dealing with tinnitus-related disturbances.…”