Clinical trial NCT03114878: The Value of EMDR in the Treatment of Tinnitus
Official title: The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2017-04-14
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: 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:
measure: Visual Analogue Scale (VAS) of loudness
timeFrame: 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.
measure: Tinnitus questionnaire (TQ)
timeFrame: 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.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
measure: Hyperacusis Questionnaire (HQ)
timeFrame: 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.
measure: Psychoacoustic measurements
timeFrame: 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.
measure: ERP
timeFrame: 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.
measure: Big Five Inventory - 2 (BFI)
timeFrame: Timeframe within 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: Chairman dept of ENT and Head and Neck Surgery, Antwerp University Hospital
name: Prof. Paul Van de Heyning, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.