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ID
Source
Brief title
Health condition
Chronic tinnitus
Sponsors and support
This project has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement number 722046.
Adelante, Centre of Expertise in Rehabilitation and Audiology
NWO Veni grant number 016.165.105.
Intervention
Outcome measures
Primary outcome
Tinnitus disability as measured through daily diaries and ecological momentary assessments.
Secondary outcome
Tinnitus Functional Inventory (TFI)
Background summary
Specialised cognitive behavioural therapy (CBT) for tinnitus is a complex intervention comprised of many components. Recent research has demonstrated that it is effective in significantly reducing the impact tinnitus has in daily life for people suffering from it. What is unknown is the impact that the respective components have on reducing distress and interference in daily activities. In this project, comprised of three studies, components of specialised CBT for tinnitus (e.g. audiological and psychological assessment, education, relaxation, exposure and group effects) will be closely examined to reveal what role they play in facilitating change in patients’ thoughts, emotions and behaviours. In this particular study, exposure and relaxation components are isolated to assess the positive, negative or lack of effect that these components have on tinnitus disability.
Study objective
To explore the positive, negative or lack of effect that these components have (isolated and combined) on tinnitus disability.
Study design
From inclusion to 3 month follow-up assessment.
Intervention
Exposure and relaxation protocols of the established CBT for Tinnitus intervention.
Matheus Lourenco
+31 (0) 4 33 88 24 68
matheus.lourenco@maastrichtuniversity.nl
Matheus Lourenco
+31 (0) 4 33 88 24 68
matheus.lourenco@maastrichtuniversity.nl
Inclusion criteria
In order to be eligible to participate in this study, a person must meet all of the following criteria. That is they must:
• Be primarily seeking treatment/help for difficulties caused by subjective tinnitus
• Be at least 18 years of age
• Have at least moderate tinnitus related distress (i.e. TQ score > 30)
Exclusion criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study:
• Severe depression or anxiety as measured by Dutch version of DASS-21.
• Any person who discloses current suicidal intent.
• Currently or undertaken any treatment for tinnitus (e.g. CBT, tinnitus retraining therapy ) within the previous 5 years (including the aforementioned RCT)
• Potential participant has reported to have commenced or ceased a course of antidepressants [i.e. selective serotonin re-uptake inhibitors (SSRIs); selective serotonin and norepinephrine re-uptake inhibitors (SNRIs); atypical antidepressants, tricyclic antidepressants, or monoamine oxidase inhibitors], antipsychotics [Aripiprazole (Abilify), Asenapine (Saphris), Brexpiprazole (Rexulti), Cariprazine (Vraylar), Clozapine (Clozaril), Iloperidone (Fanapt), Lurasidone (Latuda), Olanzapine (Zyprexa), Paliperidone (Invega), Quetiapine (Seroquel), Risperidone (Risperdal), Ziprasidone (Geodon), Haloperidol], anxioltytics [beta blockers, benzodiazepines], Ritalin, hormone replacement therapy, or medication to lower high blood pressure (i.e. thiazide diuretics, ACE inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, renin inhibitors] within the previous 3 months.
• Currently receiving psychological or any other kind of therapy addressing psychological, social, emotional, and or behavioural problems
• Unable to read and write fluently in Dutch
• Commenced the use of a hearing aid in the previous 3 months
• Has hearing loss greater than 40dB in one or both ears
• Having previously participated in a study from this project.
Design
Recruitment
IPD sharing statement
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7826 |
| CCMO | NL63262.015.18 |
| OMON | NL-OMON46739 |