A treatment components analysis of a stepped-care, CBT based treatment for adults with tinnitus: a replicated single-case experimental approach

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoints will include measures related to cognitive,<br /><br>emotional and behavioural responses to living with tinnitus. For example,<br /><br>ratings of annoyance, depression, anxiety, stress, fear related cognitions<br /><br>about tinnitus, catastrophizing about living with tinnitus, acceptance of<br /><br>tinnitus, and quality of life. This data will be collected on a daily basis via<br /><br>the smartphone app. See document C1 for details.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcome is the Tinnitus Functional Inventory (TFI; Meikle<br /><br>et al., 2012) which is a measure of the level of interference tinnitus causes<br /><br>in a person*s daily activities. It has been assessed and recommended as being a<br /><br>suitable outcome measure for tinnitus related treatments and is responsive to<br /><br>change (Fackrell, Hall, Barry, & Hoare, 2014). </p><br>