The Value of EMDR in the Treatment of Tinnitus

NCT ID: NCT03114878

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-01-31

Brief Summary

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

Detailed Description

Patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT and CBT versus TRT and EMDR. Evaluations will take place at baseline before therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3 months after therapy ends. The Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements will be 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). 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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TRT / EMDR

Tinnitus Retraining Therapy / Eye Movement Desensitization Reprocessing

Group Type: ACTIVE_COMPARATOR

TRT / CBT

Intervention Type: 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.

TRT / CBT

Tinnitus Retraining Therapy / Cognitive Behavioral Therapy

Group Type: ACTIVE_COMPARATOR

TRT / EMDR

Intervention Type: 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.

Interventions

TRT / EMDR

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.

Intervention Type: OTHER

TRT / CBT

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TRT / Eye Movement Desensitization Reprocessing; TRT / Cognitive Behavioral Therapy

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Tine Luyten

Tine Luyten Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Paul Van de Heyning, MD PhD

Role: STUDY_DIRECTOR

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

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33013517 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30626414 (View on PubMed)

Other Identifiers

ECUZA16/35/360

Identifier Type: -

Identifier Source: org_study_id