Cost-effectiveness of Multidisciplinary Management of Tinnitus
NCT ID: NCT00733044
Last Updated: 2013-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
492 participants
INTERVENTIONAL
2007-09-30
2012-07-31
Brief Summary
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Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months.
Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be from a societal perspective.
Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Specialized Care
Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy
Specialized Care
The intervention consists of the integration of integral tinnitus management provided by a specialized tinnitus centre in the health care system. The tinnitus centre offers care following a stepped-care approach with two levels. The first level of intervention consists of audiological diagnostics and intervention, a tinnitus educational group session and a individual consult with a clinical psychologist. For patients with mild complaints this basic intervention is expected to suffice. For patients with moderate to severe complaints a second level of intervention exists. This level of intervention consists of combinations of the following therapies: Cognitive Behavioural Therapy (CBT), Attention Diversion (AD), exposure techniques, and Relaxation Therapy (RT).
Usual Care
Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session
Usual Care
Usual care consists of a standardized version of treatment that is currently applied in peripheral audiological centres throughout the Netherlands. A telephone survey was conducted amongst all audiological centres (n=28) in the Netherlands. The results of this survey determined the content of the usual care treatment protocol in the current study. The treatment consists of audiological diagnostics and intervention and, if necessary, one or more consults with a social worker with a maximum of ten one hour sessions.
Interventions
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Specialized Care
The intervention consists of the integration of integral tinnitus management provided by a specialized tinnitus centre in the health care system. The tinnitus centre offers care following a stepped-care approach with two levels. The first level of intervention consists of audiological diagnostics and intervention, a tinnitus educational group session and a individual consult with a clinical psychologist. For patients with mild complaints this basic intervention is expected to suffice. For patients with moderate to severe complaints a second level of intervention exists. This level of intervention consists of combinations of the following therapies: Cognitive Behavioural Therapy (CBT), Attention Diversion (AD), exposure techniques, and Relaxation Therapy (RT).
Usual Care
Usual care consists of a standardized version of treatment that is currently applied in peripheral audiological centres throughout the Netherlands. A telephone survey was conducted amongst all audiological centres (n=28) in the Netherlands. The results of this survey determined the content of the usual care treatment protocol in the current study. The treatment consists of audiological diagnostics and intervention and, if necessary, one or more consults with a social worker with a maximum of ten one hour sessions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Referred to Tinnitus centre Limburg
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Maastricht University
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Iris Maes
MSc
Principal Investigators
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Johan WS Vlaeyen, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Manuela A Joore, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Lucien J Anteunis, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Hoensbroeck Audiological Centre
Hoensbroek, Limburg, Netherlands
Countries
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References
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Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
Cima R, Joore M, Maes I, Scheyen D, Refaie AE, Baguley DM, Vlaeyen JW, Anteunis L. Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre. BMC Health Serv Res. 2009 Feb 11;9:29. doi: 10.1186/1472-6963-9-29.
Other Identifiers
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ZonMw 80-007022-98-07715
Identifier Type: -
Identifier Source: secondary_id
06-0012
Identifier Type: -
Identifier Source: org_study_id
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