Tinnitus: ringing of the ears
Conditions
Interventions
Specialised stepped-care CBT for tinnitus.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Be primarily seeking treatment/help for difficulties caused by subjective tinnitus • Be at least 18 years of age • Have moderate tinnitus related distress (i.e. TQ score > 30);Additional inclusion criteria specific to Study 2 and 3: Completed Step 1 of specialised care and eligible to continue with Step 2 of specialised care for tinnitus.
Exclusion criteria
Exclusion criteria: • 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 TRT, medication) 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 antidepessants, 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.;• Receiving psychological or any other kind of therapy addressing 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoints will include measures related to cognitive, emotional and behavioural responses to living with tinnitus. For example, ratings of annoyance, depression, anxiety, stress, fear related cognitions about tinnitus, catastrophizing about living with tinnitus, acceptance of tinnitus, and quality of life. This data will be collected on a daily basis via the smartphone app. See document C1 for details. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study outcome is the Tinnitus Functional Inventory (TFI; Meikle et al., 2012) which is a measure of the level of interference tinnitus causes in a person*s daily activities. It has been assessed and recommended as being a suitable outcome measure for tinnitus related treatments and is responsive to change (Fackrell, Hall, Barry, & Hoare, 2014). | — |
Countries
Netherlands
Outcome results
None listed