Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.
- Conditions
- Tinnitus, Subjective
- Interventions
- Behavioral: CBT 1Behavioral: CBT 2
- Registration Number
- NCT04310605
- Lead Sponsor
- Maastricht University
- Brief Summary
This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- Tinnitus is the primary complaint and reason for seeking help
- Participant is at least 17 years of age,
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Step 1 and 2 CBT 1 Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus. Step 1 and 2 CBT 2 Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus. Step 1 only CBT 1 Participants in the study who only receive Step 1 of specialised CBT
- Primary Outcome Measures
Name Time Method Health Utilities Index-III 12 months 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.
- Secondary Outcome Measures
Name Time Method Tinnitus Handicap Inventory (THI) 12 months 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.
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). 12 months 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").
Fear of Tinnitus Questionnaire (FTQ) 12 months 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.
Tinnitus Catastrophizing Scale (TCS) 12 months 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.
Tinnitus Questionnaire (TQ) 12 months 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.
Tinnitus Disability Index (TDI) 12 months 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.