TinnitusNCT03114878
The Value of EMDR in the Treatment of Tinnitus
A study testing TRT / EMDR and TRT / CBT in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- TRT / EMDR and TRT / CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus
A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.
Read the 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
- Being tested
- TRT / EMDR, TRT / CBT
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRT / EMDROther
Also called TRT / Eye Movement Desensitization Reprocessing
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.
TRT / CBTBehavioural
Also called TRT / Cognitive Behavioral Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| TRT / EMDR | Active comparator | Tinnitus Retraining Therapy / Eye Movement Desensitization Reprocessing Receives: Behavioral: TRT / CBT |
| TRT / CBT | Active comparator | Tinnitus Retraining Therapy / Cognitive Behavioral Therapy Receives: Other: TRT / EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The patient scores the mean and maximum loudness of their tinnitus on a scale of 0 (absence of tinnitus) to 10 (as loud as possible, cannot be any louder).
Measured: 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)
The TQ is a 52-item self-rating scale, which differentiates between dimensions of emotional and cognitive distress, intrusiveness, auditory perceptual difficulties, sleep disturbances and somatic complaints. The patient rates the items on a 3-point scale.
Measured: 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)
The HADS consists of 14 questions that assess anxiety and depression. The patient can choose between four answer options for each question. The score for both components is a summation of the scores of all the questions belonging to the subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder.
Measured: 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)
The HQ is a 14-item questionnaire that surveys a patient's hypersensitivity to sound. There are four answer options for every question: 'no', 'yes a little', 'yes quite a lot' and 'yes a lot'. A score of 28 is the cut-off for auditory hypersensitivity.
Measured: 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
In order to categorize our patient group, all subjects will undergo an audiometric hearing test according to current clinical standards (International Organisation for Standardization (ISO) 8253-1:2010) with a 2-channel Interacoustics AC 40 (Interacoustics A/S, Middelfart, Denmark) in a soundproof audiometric booth. The TDH-39 headphone is used as transducer to measure air conduction thresholds of frequencies ranging from 125 Hz to 8 kHz. If air conduction thresholds exceed 20 dB HL, bone conduction thresholds will be determined within a range of 250 Hz to 4 kHz.
The frequency of tinnitus will be determined by means of frequency matching for which a forced choice technique is applied. The patient must choose between two presented tones or noises until a tone or noise is found that is similar to the patient's tinnitus.
Measured: 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.
ERP
In this study, the emphasis is on the late auditory evoked potentials which will be evoked by use of a classical oddball paradigm. As such a standard tone of 1 kHz is repeated with a probability of 80% randomly interrupted by an oddball (or infrequent) tone of 2 kHz with a probability of 20%. This paradigm elicits late auditory evoked potentials comprising of P1-N1-P2 and P300 of which the first complex is mostly generated by bottom-up processes in the brain. The later P300 potential requires more top-down cognitive brain processes and can be seen as an expression of higher cognitive sound processing in tinnitus patients. The hypothesis is that, given the continuous auditory processing of the tinnitus signal, the brain may have less capacity left to align to other incoming stimuli which may be altered by therapy.
The late auditory potentials will be measured prior to the therapy, after the therapy and 3 months later.
Measured: 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.
Big Five Inventory - 2 (BFI)
BFI-2 (Soto \& John, 2017) is self-report questionnaire contains 60 items with a forced-choice of 5 items (e.g. totally disagree - disagree - don't agree/don't disagree - agree - totally agree).
Measured: Timeframe within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startOct 2016
- Primary completionSep 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Tine Luyten, University Hospital, Antwerp
- Investigators
- Prof. Paul Van de Heyning, MD PhD, Study director, Chairman dept of ENT and Head and Neck Surgery, Antwerp University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114878
- Sponsor's protocol ID
- ECUZA16/35/360
- Status last verified
- Jan 2021
- First submitted
- 20 Dec 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
Publications
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.
PubMed 33013517Luyten 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.
PubMed 30626414
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT03114878
- Acronym / sponsor ID
- ECUZA16/35/360
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Oct 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRT / EMDR | Active comparator | Behavioral: TRT / CBTTinnitus Retraining Therapy / Eye Movement Desensitization Reprocessing |
| TRT / CBT | Active comparator | Other: TRT / EMDRTinnitus Retraining Therapy / Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRT / EMDRAlso: TRT / Eye Movement Desensitization ReprocessingTinnitus 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. | Other | TRT / CBT |
| TRT / CBTAlso: TRT / Cognitive Behavioral TherapyTinnitus 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. | Behavioural | TRT / EMDR |
Primary outcome
Tinnitus Functional Index (TFI)
Time frame: 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.
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.
7 secondary outcomes
Visual Analogue Scale (VAS) of loudness
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
ERP
Time frame: 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.
Big Five Inventory - 2 (BFI)
Time frame: Timeframe within 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 33013517Luyten 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.
- Derived from this study: PubMed 30626414Luyten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Paul Van de Heyning, MD PhD study director
Chairman dept of ENT and Head and Neck Surgery, Antwerp University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRT / EMDR and TRT / CBT in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (TFI) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114878, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.