TinnitusPhase 4TCPNCT00719940
Tinnitus Treatment by Structured Cognitive Behavioral Therapy
A Phase 4 study testing Cognitive behavioral therapy and Waiting group in people with Tinnitus, run by University Hospital Tuebingen at 4 sites in Germany.
Trial summary
Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cognitive behavioral therapy and Waiting group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2000to Nov 2006
- Phase
- Phase 4
- 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 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent and stable tinnitus of more than 11 weeks
- Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale
Who cannot join
- Psychiatric or neurological comorbidity
- Tinnitus as concomitant symptom of an otherwise treatable disease
- Drug treatment for tinnitus 24 hrs. prior or during therapy
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Tinnitus Care Center
Aschaffenburg, 63739
Tinnitus Care Center
Frankfurt, 60594
Dept. ORL, University of Tuebingen
Tübingen, 72070
Private Practice
Tübingen, 72070
About this study
Official title: Randomized Controlled Clinical Trial of Efficacy and Safety of Individual Cognitive Behavioral Therapy (CBT) Within the Setting of the Structured Therapy Program sTCP (Structured Tinnitus Care Program) in Patients With Tinnitus Aurium
Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.
Read the detailed description
Intervention:
Individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (TCP)"
Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks
Control intervention: Waiting group (16 weeks)
- Conditions
- Tinnitus
- Being tested
- Cognitive behavioral therapy, Waiting group
- Keywords
- tinnitus, cognitive behavioral therapy, CBT
- Medical subject headings
- Tinnitus, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Also called tinnitus care program
1-15 individual sessions of 50-60 min. to apply 1-15 manualized tinnitus specific cognitive behavioral therapy interventions structured by the tinnitus care disease management program
Waiting groupOther
Also called tinnitus care program
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy |
| 2 | Placebo comparator | Waiting group Receives: Other: Waiting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
Measured: Last session
Secondary outcomes (1)
Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale
Measured: last therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startOct 2000
- Primary completionOct 2004
- Study completionNov 2006
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Hans P. Zenner, M.D., Principal investigator, Universität Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719940
- Sponsor's protocol ID
- TCP00/04
- Other IDs
- BMBF 01EZ0506: Dekonet;, Mediceon: Benchmarking project
- Acronym
- TCP
- Status last verified
- Jun 2008
- First submitted
- 16 Jun 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Zenner HP, De Maddalena H. Validity and reliability study of three tinnitus self-assessment scales: loudness, annoyance and change. Acta Otolaryngol. 2005 Nov;125(11):1184-8. doi: 10.1080/00016480510012282.
PubMed 16353397Zenner HP, Vonthein R, Zenner B, Leuchtweis R, Plontke SK, Torka W, Pogge S, Birbaumer N. Standardized tinnitus-specific individual cognitive-behavioral therapy: a controlled outcome study with 286 tinnitus patients. Hear Res. 2013 Apr;298:117-25. doi: 10.1016/j.heares.2012.11.013. Epub 2012 Dec 31.
PubMed 23287811
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Efficacy and Safety of Individual Cognitive Behavioral Therapy (CBT) Within the Setting of the Structured Therapy Program sTCP (Structured Tinnitus Care Program) in Patients With Tinnitus Aurium
- ClinicalTrials.gov ID
- NCT00719940
- Acronym / sponsor ID
- TCP / TCP00/04
- Conditions
- Tinnitus
- Keywords
- tinnitus, cognitive behavioral therapy, CBT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Oct 2004 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Jul 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.
Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.
Detailed description
Intervention:
Individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (TCP)"
Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks
Control intervention: Waiting group (16 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavioral therapyCognitive behavioral therapy |
| 2 | Placebo comparator | Other: Waiting groupWaiting group |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent and stable tinnitus of more than 11 weeks
- Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale
Key exclusion criteria (3 listed)
- Psychiatric or neurological comorbidity
- Tinnitus as concomitant symptom of an otherwise treatable disease
- Drug treatment for tinnitus 24 hrs. prior or during therapy
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 |
|---|---|---|
| Cognitive behavioral therapyAlso: tinnitus care program1-15 individual sessions of 50-60 min. to apply 1-15 manualized tinnitus specific cognitive behavioral therapy interventions structured by the tinnitus care disease management program | Behavioural | 1 |
| Waiting groupAlso: tinnitus care programNo intervention | Other | 2 |
Primary outcome
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
Time frame: Last session
1 secondary outcome
Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale
Time frame: last therapy session
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 22 Jul 2008.
- Results publication: PubMed 16353397Zenner HP, De Maddalena H. Validity and reliability study of three tinnitus self-assessment scales: loudness, annoyance and change. Acta Otolaryngol. 2005 Nov;125(11):1184-8. doi: 10.1080/00016480510012282.
- Derived from this study: PubMed 23287811Zenner HP, Vonthein R, Zenner B, Leuchtweis R, Plontke SK, Torka W, Pogge S, Birbaumer N. Standardized tinnitus-specific individual cognitive-behavioral therapy: a controlled outcome study with 286 tinnitus patients. Hear Res. 2013 Apr;298:117-25. doi: 10.1016/j.heares.2012.11.013. Epub 2012 Dec 31.
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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.
Hans P. Zenner, M.D. principal investigator
Universität Tübingen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive behavioral therapy and Waiting group in people with Tinnitus, run by University Hospital Tuebingen at 4 sites in Germany.
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 3 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 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) (time frame: Last session). 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 NCT00719940, 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 22 Jul 2008.