TinnitusNCT00733044
Cost-effectiveness of Multidisciplinary Management of Tinnitus
A study testing Specialized Care in people with Tinnitus, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Specialized Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective tinnitus complaints
- Referred to Tinnitus centre Limburg
Who cannot join
- Not being able to write and read in Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Hoensbroeck Audiological Centre
Hoensbroek, Limburg, 6432CC
About this study
Official title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.
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.
Read more
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.
- Conditions
- Tinnitus
- Being tested
- Specialized Care, Usual Care
- Keywords
- Objective tinnitus, Tinnitus, RCT, Specialised treatment, Usual care, Cost-effectiveness
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized CareBehavioural
Also called Multidisciplinary 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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialized Care | Experimental | Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy Receives: Behavioral: Specialized Care |
| Usual Care | Active comparator | Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)
Measured: At baseline and 3, 8 and 12 months follow-up
Secondary outcomes (6)
Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)
Measured: At baseline and at 3, 8 and 12 months follow-up
Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)
Measured: At baseline and at 3, 8 and 12 months follow-up
Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)
Measured: At baseline and at 3, 8 and 12 months follow-up
Dysfunctional beliefs and/or cognitions regarding the tinnitus, as measured with the Tinnitus Coping and Cognition list (TCCL)
Measured: At baseline and at 3, 8 and 12 months follow-up
Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).
Measured: At baseline and at 3, 8 and 12 months follow-up
Costs, as measured with a retrospective cost questionnaire
Measured: At baseline and at 3,8 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionNov 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Iris Maes, Maastricht University Medical Center
- Investigators
- Johan WS Vlaeyen, Prof, PhD, Principal investigator, Maastricht UniversityManuela A Joore, PhD, Principal investigator, Maastricht University Medical CenterLucien J Anteunis, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733044
- Sponsor's protocol ID
- 06-0012
- Other IDs
- ZonMw 80-007022-98-07715
- Status last verified
- May 2013
- First submitted
- 7 Aug 2008
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22633033Cima 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.
PubMed 19210767
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
- ClinicalTrials.gov ID
- NCT00733044
- Acronym / sponsor ID
- 06-0012
- Conditions
- Tinnitus
- Keywords
- Objective tinnitus, Tinnitus, RCT, Specialised treatment, Usual care, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Sep 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized Care | Experimental | Behavioral: Specialized CareStepped-care cognitive behavioural approach with elements from tinnitus retraining therapy |
| Usual Care | Active comparator | Other: Usual CareAudiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjective tinnitus complaints
- Referred to Tinnitus centre Limburg
Key exclusion criteria (1 listed)
- Not being able to write and read in Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized CareAlso: Multidisciplinary careThe 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). | Behavioural | Specialized Care |
| Usual CareUsual 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 | Usual Care |
Primary outcome
Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3)
Time frame: At baseline and 3, 8 and 12 months follow-up
6 secondary outcomes
Tinnitus related disability and handicap as measured with the Tinnitus Handicap Inventory (THI)
Time frame: At baseline and at 3, 8 and 12 months follow-up
Tinnitus annoyance and severity, as measured with the Tinnitus Questionnaire (TQ)
Time frame: At baseline and at 3, 8 and 12 months follow-up
Tinnitus-related fear was assessed by the Fear of Tinnitus Questionnaire (FTQ)
Time frame: At baseline and at 3, 8 and 12 months follow-up
Dysfunctional beliefs and/or cognitions regarding the tinnitus, as measured with the Tinnitus Coping and Cognition list (TCCL)
Time frame: At baseline and at 3, 8 and 12 months follow-up
Catastrophic (mis)interpretations of tinnitus, as measured with the Tinnitus Catastrophising Scale (TCS).
Time frame: At baseline and at 3, 8 and 12 months follow-up
Costs, as measured with a retrospective cost questionnaire
Time frame: At baseline and at 3,8 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Derived from this study: PubMed 22633033Cima 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.
- Derived from this study: PubMed 19210767Cima 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan WS Vlaeyen, Prof, PhD principal investigator
Maastricht University
Manuela A Joore, PhD principal investigator
Maastricht University Medical Center
Lucien J Anteunis, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Care in people with Tinnitus, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (time frame: At baseline and 3, 8 and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.