COGNITIVE BEHAVIOR THERAPY FOR TINNITUS RELATED INSOMNIA: A SINGLE-CASE EXPERIMENT

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Be primarily seeking treatment/help for difficulties caused by tinnitus.
- Additionally complaints of sleep disturbance (e.g. insomnia).
- Recommended to start CBTi protocol.
- Be at least 18 years of age.
- Have at least a score of 47 in the Tinnitus Questionnaire
- Have at least a score of 10 on the Insomnia Severity Index

Exclusion Criteria

- Any person who discloses current suicidal intent.
- Severe anxiety or depression (as measured by having at least a score of 14 on
the HADS-A and/or HADS-D.)
- Pregnancy of potential participant or partner.
- Currently undergoing any treatment for tinnitus (e.g. Tinnitus Retraining
Therapy).
- 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
- Unable to read and write fluently in Dutch.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Participants* sleep diary is the main parameter for this study. Sleep onset<br /><br>latency, wake time after sleep onset, number of awakenings and sleep quality<br /><br>can be calculated for each night. The participant completes the diary on paper<br /><br>and delivers to the therapist at each session (treatment as usual). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Participants* tinnitus diary will be used to identify changes in tinnitus<br /><br>experience. The diary is composed of 16 questions related to tinnitus<br /><br>experience (e.g. how annoying was your tinnitus today?), avoidance (e.g.<br /><br>What proportion of the day have you used a device / television / radio etc to<br /><br>mask your tinnitus?), avoidance and emotion (e.g. how angry did you tinnitus<br /><br>make you today?). </p><br>