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| ID | Type | Description | Link |
|---|---|---|---|
| BMBF 01EZ0506: Dekonet; | |||
| Mediceon: Benchmarking project |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cognitive behavioral therapy |
|
| 2 | Placebo Comparator | Waiting group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) | Last session |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale | last therapy session |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans P. Zenner, M.D. | Universität Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tinnitus Care Center | Aschaffenburg | 63739 | Germany | |||
| Tinnitus Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16353397 | Result | 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. | |
| 23287811 | Derived | Zenner 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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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Waiting group | Other | No intervention |
|
|
| Frankfurt |
| 60594 |
| Germany |
| Dept. ORL, University of Tuebingen | Tübingen | 72070 | Germany |
| Private Practice | Tübingen | 72070 | Germany |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |