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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04310605
Enrollment
403
Registered
2020-03-17
Start date
2014-01-01
Completion date
2016-11-16
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus, Subjective

Keywords

tinnitus, CBT, cognitive behaviour therapy

Brief summary

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

Interventions

BEHAVIORALCBT 1

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).

BEHAVIORALCBT 2

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.

Sponsors

SWOL Limburgs Fonds voor Revalidatie
CollaboratorUNKNOWN
Flemish Government, Belgium
CollaboratorUNKNOWN
The Netherlands Organization for Scientific Research (NWO)
CollaboratorUNKNOWN
Libra Revalidatie en Audiologie
CollaboratorUNKNOWN
Maastricht University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Health Utilities Index-III12 monthsThe 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

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).12 monthsThe 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).
Tinnitus Catastrophizing Scale (TCS)12 monthsTinnitus 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 Handicap Inventory (THI)12 monthsThe 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.
Tinnitus Questionnaire (TQ)12 monthsThe 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 monthsThe 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.
Fear of Tinnitus Questionnaire (FTQ)12 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026