The Value of EMDR in the Treatment of Tinnitus

NCT03114878 | Completed

• 1 other identifier: ECUZA16/35/360
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index (TFI)

  The TFI is a self-reported questionnaire, consisting of 25 questions, which assesses the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0 % to 100 %. The total score is calculated with the mean of all questions. The answers are converted and the total score is expressed as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease in the score on the TFI in the TRT-CBT-treatment group versus a decrease in the TFI-score in the TRT- EMDR-treatment group is the primary focus of attention in this study.

  Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.

Secondary Outcomes (7)

• Visual Analogue Scale (VAS) of loudness

  There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.

• Tinnitus questionnaire (TQ)

  There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.

• Hospital Anxiety and Depression Scale (HADS)

  There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.

• Hyperacusis Questionnaire (HQ)

  There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.

• Psychoacoustic measurements

  There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).These measurements will only be used to evaluate within-patient variability.

Study Arms (2)

TRT / EMDR

ACTIVE COMPARATOR

Tinnitus Retraining Therapy / Eye Movement Desensitization Reprocessing

Behavioral: TRT / CBT

TRT / CBT

ACTIVE COMPARATOR

Tinnitus Retraining Therapy / Cognitive Behavioral Therapy

Other: TRT / EMDR

Interventions

TRT / EMDR OTHER

Tinnitus Retraining Therapy: TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears. Eye Movement Desensitization and Reprocessing: This is a scientifically, psychotherapeutic approach, developed in 1987 by Francine Shapiro. EMDR represents a specific method within a wider theoretical model called 'Adaptive Information Processing (AIP)'. Within the treatment bilateral stimulation is used i.e. visual, auditory and tactile stimuli can be used to stimulate both the left - and the right hemisphere.

Also known as: TRT / Eye Movement Desensitization Reprocessing

TRT / CBT

TRT / CBT BEHAVIORAL

Tinnitus Retraining Therapy: TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears. Cognitive Behavioral Therapy: CBT is the combination of behavioral therapy with interventions that have been developed from cognitive psychology. The founders of CBT are Aaron Beck and Albert Ellis. The core idea is the assumption that so-called negative cognitions are responsible for dysfunctional behavior. The techniques used in the cognitive behavioral therapy focus on changing the content of these irrational cognitions.

Also known as: TRT / Cognitive Behavioral Therapy

TRT / EMDR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tinnitus type: chronic, subjective, non - pulsatile tinnitus
• Duration of tinnitus = more than 3 months
• Minimum age of the patient is 18 years old - maximum age is 75 years old
• Tinnitus Functional Index (TFI) score ≥ 25 - \< 90
• Stable use of medication during therapy

You may not qualify if:

• HADS - score: anxiety and depression-subscores \> 15
• HQ - score \> 40
• Objective, pulsatile tinnitus
• Active middle ear pathology
• Neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing
• Psychosis, schizophrenia, epilepsy
• Pregnancy

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (2)

• Luyten TR, Jacquemin L, Van Looveren N, Declau F, Fransen E, Cardon E, De Bodt M, Topsakal V, Van de Heyning P, Van Rompaey V, Gilles A. Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT. Front Psychol. 2020 Sep 10;11:2048. doi: 10.3389/fpsyg.2020.02048. eCollection 2020.

  PMID: 33013517 DERIVED

• Luyten T, Van de Heyning P, Jacquemin L, Van Looveren N, Declau F, Fransen E, Gilles A. The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial. Trials. 2019 Jan 9;20(1):32. doi: 10.1186/s13063-018-3121-6.

  PMID: 30626414 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Eye Movement Desensitization Reprocessing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prof. Paul Van de Heyning, MD PhD

  Chairman dept of ENT and Head and Neck Surgery, Antwerp University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tine Luyten Clinical Psychologist

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: April 14, 2017
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

BE (1)