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Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719940
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : July 22, 2008
Information provided by:
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Tinnitus Behavioral: Cognitive behavioral therapy Other: Waiting group Phase 4

Detailed Description:


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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2000
Actual Primary Completion Date : October 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) [ Time Frame: Last session ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719940

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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
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Principal Investigator: Hans P. Zenner, M.D. Universität Tübingen
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zenner, H.P., M.D., Professor & Chairman, Dept. ORL, University of Tuebingen, Germany, University Hospital, University of Tuebingen, Germany Identifier: NCT00719940    
Other Study ID Numbers: TCP00/04
BMBF 01EZ0506: Dekonet;
Mediceon: Benchmarking project
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: June 2008
Keywords provided by University Hospital Tuebingen:
tinnitus, cognitive behavioral therapy, CBT
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms