The main objective of this study proposal is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialised tinnitus center.
ID
Source
Brief title
Condition
- Aural disorders NEC
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life
Secondary outcome
Negative affect, severity of tinnitus, illness cognitions, fear of tinnitus,
and costs.
Background summary
Tinnitus is the involuntary perception of the concept of a sound without the
presence of an external source. Little is known about the pathophysiology and
consequently few treatments are standardized or evaluated. In the Netherlands
about 2 million persons experience tinnitus. In a minority (approximately 3%:
ca. 60.000 individuals) it causes severe affective problems and a decrease in
quality of life. The lack of correct information, appropriate guidance and
multidisciplinary treatment creates undue frustration, anxiety and
deterioration of the condition, which in turn leads to increased health
services utilization and prolongation of the referral trajectory. Evidence
suggests that an integral multidisciplinary approach in treating tinnitus is
effective. The Tinnitus Center Limburg (TCL) founded within Hoensbroeck
Audiological Center, offers evidence-based specialised integral tinnitus
management programs, executed by several disciplines.
Study objective
The main objective of this study proposal is to examine the effectiveness,
costs, and cost-effectiveness of an integral treatment provided by a
specialised tinnitus center.
Study design
In a randomised controlled trial 394 tinnitus patients will be randomly
assigned to a
specialised tinnitus care group or a usual care group. The duration of
follow-up is 12 months. Inclusion: 18 years or older experiencing subjective
tinnitus. Exlusion: Not able to read and/or write in the Dutch language.
Intervention
Treatment is based on a stepped-care approach, tailored to individual patient
needs, with key elements from cognitive behavioural therapy, education,
relaxation techniques, attention diversion, exposure to daily live situations,
and tinnitus retraining therapy.
Study burden and risks
Burden or risk associated with participation is expected to be minimal.
Subjects are aked to fill in a number of questionnaires, which are next to
research purposes, necessary for treatmentdiagnostics, except for the
cost-questionnaire.
Zandbergsweg 111
6432 CC Hoensbroek
Nederland
Zandbergsweg 111
6432 CC Hoensbroek
Nederland
Listed location countries
Age
Inclusion criteria
Subjective tinnitus
Exclusion criteria
Not able to read and/or write in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL12965.022.06 |