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

Jonas Eimontas; Goda Gegieckaitė; Irena Asačiova; Nikol Stičinskaitė; Livija Arcimavičiūtė; Dovilė Savickaitė; Donata Vaitiekūnaitė-Zubriakovienė; Marius Polianskis; Jennifer Gans; Eldre Beukes; Vinaya Manchaiah; Gerhard Andersson; Eugenijus Lesinskas

doi:10.1186/s13063-023-07299-9

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

Trials. 2023 Apr 12;24(1):269. doi: 10.1186/s13063-023-07299-9.

Authors

Jonas Eimontas¹, Goda Gegieckaitė², Irena Asačiova³, Nikol Stičinskaitė³, Livija Arcimavičiūtė³, Dovilė Savickaitė³, Donata Vaitiekūnaitė-Zubriakovienė^{4

5}, Marius Polianskis⁶, Jennifer Gans⁷, Eldre Beukes^{8

9}, Vinaya Manchaiah^{9

10

11

12

13

14}, Gerhard Andersson^{15

16}, Eugenijus Lesinskas⁶

Affiliations

¹ Department of Clinical Psychology, Institute of Psychology, Vilnius University, Vilnius, Lithuania. jonas.eimontas@fsf.vu.lt.
² Department of Clinical Psychology, Institute of Psychology, Vilnius University, Vilnius, Lithuania.
³ Institute of Psychology, Vilnius University, Vilnius, Lithuania.
⁴ Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
⁵ Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
⁶ Clinic of Ear, Nose, Throat and Eye Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
⁷ Mindfulness Based Tinnitus Stress Reduction (MBTSR), San Francisco, CA, USA.
⁸ Vision and Hearing Sciences Research Centre, Anglia Ruskin University, Cambridge, UK.
⁹ Virtual Hearing Lab, Collaborative Initiative Between University of Colorado School of Medicine and University of Pretoria, Aurora, CO, USA.
¹⁰ Department of Otolaryngology-Head and Neck Surgery, University of Colorado School of Medicine, Aurora, CO, USA.
¹¹ UC Health Hearing and Balance, University of Colorado Hospital, Aurora, CO, USA.
¹² University of Pretoria, Pretoria, South Africa.
¹³ Department of Speech-Language Pathology and Audiology, University of Pretoria, Gauteng, South Africa.
¹⁴ Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.
¹⁵ Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
¹⁶ Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Abstract

Background: Tinnitus affects around 15% of the population and can be a debilitating condition for a sizeable part of them. However, effective evidence-based treatments are scarce. One recommended treatment for tinnitus is cognitive behavioral therapy which has been found to be effective when delivered online. However, more treatments including mindfulness-based interventions have been studied recently in an attempt to facilitate the availability of effective treatments. There are promising findings showing great effects in reducing tinnitus-induced distress and some evidence about the efficacy of such intervention delivered online. However, there is a lack of evidence on how these two treatments compare against one another. Therefore, the aim of this study will be to compare Internet-delivered cognitive behavioral therapy for tinnitus against an Internet-delivered mindfulness-based tinnitus stress reduction intervention in a three-armed randomized controlled trial with a waiting list control condition.

Methods: This study will be a randomized controlled trial seeking to recruit Lithuanian-speaking individuals suffering from chronic tinnitus. The self-report measure Tinnitus Handicap Inventory will be used. Self-referred participants will be randomized into one of three study arms: Internet-delivered cognitive behavioral therapy, Internet-delivered mindfulness-based tinnitus stress reduction intervention, or a waiting-list control group. Post-treatment measures will be taken at the end of the 8-week-long intervention (or waiting). Long-term efficacy will be measured 3 and 12 months post-treatment.

Discussion: Internet-delivered interventions offer a range of benefits for delivering evidence-based treatments. This is the first randomized controlled trial to directly compare Internet-delivered CBT and MBTSR for tinnitus in a non-inferiority trial.

Trial registration: ClinicalTrials.gov NCT05705323. Registered on January 30, 2023.

Keywords: CBT; Cognitive behavioral therapy; ICBT; Internet-delivered interventions; MBTSR; Mindfulness; RCT; Tinnitus; Tinnitus distress; iMBTSR.

Publication types

Clinical Trial Protocol

MeSH terms

Cognitive Behavioral Therapy* / methods
Humans
Internet
Mindfulness*
Randomized Controlled Trials as Topic
Tinnitus* / diagnosis
Tinnitus* / psychology
Tinnitus* / therapy
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05705323

Grants and funding

S-PD-22-178/Lietuvos Mokslo Taryba