The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial.

BACKGROUND

Patients suffering from chronic, subjective tinnitus are on a quest to find a cure or any form of alleviation for their persistent complaint. Current recommended therapy forms provide psychotherapeutic interventions that are intended to train the patient how to deal with the tinnitus sound. Pharmaceutical managements are used to reduce secondary effects of the tinnitus sound such as sleep deprivation, emotional and concentration difficulties, but these treatments do not cure the tinnitus. Recent studies have shown that Tinnitus Retraining Therapy (TRT) significantly improves the quality of life for tinnitus patients. Furthermore, several studies have reported that cognitive behavioral therapy (CBT) relieves a substantial amount of distress by changing dysfunctional cognitions. However, when the tinnitus causes great interference with daily functioning, these treatment methods are not always sufficiently effective. Recent insights show that Eye Movement Desensitization Reprocessing (EMDR) is a highly effective therapy for medically unexplained symptoms such as chronic pain and phantom pain. In scientific research, tinnitus is compared to phantom limb pain. Starting from tinnitus as a phantom percept we therefore aim to demonstrate that the operating mechanisms of EMDR may also be an effective treatment method for patients with subjective tinnitus. The aim of this randomized controlled study with blind evaluator is to examine the effect of EMDR compared to CBT in chronic tinnitus patients. To our knowledge, there are no other studies that evaluate both methods simultaneously.

METHODS/DESIGN: A total of 166 patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT + CBT versus TRT + EMDR. The experimental group will receive the bimodal therapy TRT/EMDR and the active control group will receive the bimodal therapy TRT/CBT. Evaluations will take place at baseline before therapy, at the end of the treatment and 3 months after therapy. The score on the Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements are the Visual Analogue Scale of Loudness (VAS), Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire (HQ), psychoacoustic measurements and event-related potentials (ERP).

DISCUSSION

The objective is to evaluate whether the bimodal therapy TRT and EMDR can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives compared to the bimodal therapy TRT and CBT. So far there has been no prospective, randomized controlled, clinical trial with blind evaluator that compares CBT and EMDR as a treatment for tinnitus.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT03114878 . April 14, 2017.