Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)
This study has been completed.
Sponsor:
University Hospital Tuebingen
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00719940
First received: June 16, 2008
Last updated: July 18, 2008
Last verified: June 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Behavioral: Cognitive behavioral therapy Other: Waiting group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) [ Time Frame: Last session ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 286 |
| Study Start Date: | October 2000 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cognitive behavioral therapy
|
Behavioral: Cognitive behavioral therapy
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
Other Name: tinnitus care program
|
|
Placebo Comparator: 2
Waiting group
|
Other: Waiting group
No intervention
Other Name: tinnitus care program
|
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)
Eligibility| Ages Eligible for Study: | 14 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Persistent and stable tinnitus of more than 11 weeks
- Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale
Key Exclusion Criteria:
- Psychiatric or neurological comorbidity
- Tinnitus as concomitant symptom of an otherwise treatable disease
- Drug treatment for tinnitus 24 hrs. prior or during therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719940
Locations
| Germany | |
| Tinnitus Care Center | |
| Aschaffenburg, Germany, 63739 | |
| Tinnitus Care Center | |
| Frankfurt, Germany, 60594 | |
| Dept. ORL, University of Tuebingen | |
| Tuebingen, Germany, 72070 | |
| Private Practice | |
| Tuebingen, Germany, 72070 | |
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
| Principal Investigator: | Hans P. Zenner, M.D. | University of Tuebingen, Germany |
More Information
Publications:
| Responsible Party: | Zenner, H.P., M.D., Professor & Chairman, Dept. ORL, University of Tuebingen, Germany, University Hospital, University of Tuebingen, Germany |
| ClinicalTrials.gov Identifier: | NCT00719940 History of Changes |
| Other Study ID Numbers: | TCP00/04, BMBF 01EZ0506: Dekonet;, Mediceon: Benchmarking project |
| Study First Received: | June 16, 2008 |
| Last Updated: | July 18, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Tuebingen:
|
tinnitus, cognitive behavioral therapy, CBT |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013