Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.

Study Overview
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Brief Summary
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This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.

Official Title
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Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Behavioral: CBT 1
* Behavioral: CBT 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tinnitus is the primary complaint and reason for seeking help Participant is at least 17 years of age, Exclusion Criteria: Unable to read and write in Dutch Tinnitus is not the primary complaint Person is under 17 years of age Participant has a health condition that prevents them from attending treatment centre An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Step 1 only<br>Participants in the study who only receive Step 1 of specialised CBT | Behavioral: CBT 1<br>* CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).<br>|
| Step 1 and 2<br>Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus. | Behavioral: CBT 1<br>* CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).<br>Behavioral: CBT 2<br>* Step 2 group sessions were 2 hrs long over a 12-week period. Two therapists (a psychologist and physiotherapist) were present at any one time for Step 2 sessions. Step 2 included: psycho-education; exposure therapy; mindfulness exercises; cognitive restructuring; attention redirecting techniques; stress reduction; and, relaxation techniques. Evening sessions were also provided for participants to attend with family or partners.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Utilities Index-III | The Health Utilities Index (HUI; Feeny et al., 2002; Horsman, Furlong, Feeny, & Torrance, 2003) is a 17-item measure designed to assess health related quality of life. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI) | The THI (Newman, Jacobson, & Spitzer, 1996; Newman, Sandridge, & Jacobson, 1998).is a 25 items measure of the impact of tinnitus on daily life that includes three subscales. The subscales cover functional (mental, social/occupational and physical functioning), emotional impact and catastrophic responses to tinnitus. | 12 months | 
| Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). | The HADS is a widely used measure of psychological distress in people experiencing a concurrent physical health condition. It has 14 items and respondents use a Likert-type scale to indicate how often they have had a particular feeling in the previous week (e.g. I feel tense or wound up). | 12 months | 
| Tinnitus Catastrophizing Scale (TCS) | Tinnitus Catastrophizing Scale (TCS; Cima, Crombez, & Vlaeyen, 2011). The TCS was used to assess the degree to which people thought or expected the worst about tinnitus (i.e. catastrophizing). The TCS is a 13-item measure based on the Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) and respondents use a five point scale to indicate the degree to which statements applies to them (e.g. It's terrible and I think it's never going to get any better). The total score on the TCS ranges from 0 to 65. | 12 months | 
| Fear of Tinnitus Questionnaire (FTQ) | The FTQ is a 17-item self-report measure intended and designed to assess respondents' level of fear regarding their tinnitus. Items in the questionnaire are presented as a series of statements (e.g. I am afraid that my tinnitus will become worse) from which respondents are asked to indicate if it is applicable to their current situation. Each statement receives a score of 1 when applicable. The total score is the sum of all applicable statements and provides an overall rating of fear of tinnitus and ranges from 0 to 17. | 12 months | 
| Tinnitus Questionnaire (TQ) | The Tinnitus Questionnaire (TQ; Hallam, Jakes, & Hinchcliffe, 1988) is a self-report questionnaire designed to asses distress and interference in daily activities that is associated with tinnitus. It has 52 items and uses a three-point scale to indicate levels of distress on six subscales. The total possible score on the TQ ranges from 0-84. | 12 months | 
| Tinnitus Disability Index (TDI) | The Tinnitus Disability Index (TDI; Cima, Vlaeyen, Maes, Joore, & Anteunis, 2011) is a seven-item self-report questionnaire that assesses the level of interferences in daily activities (such as occupational, social, and recreational) attributed to tinnitus. Respondents use an 11-point scale to indicate the level of interference ranging from 0 no disability, to 10 total disability. The total score ranges from 0 to 70 with higher scores indicating higher levels of interference. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, CBT, cognitive behaviour therapy