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Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719940
First Posted: July 22, 2008
Last Update Posted: July 22, 2008
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.
Information provided by:
University Hospital Tuebingen
  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
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

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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. Universität Tübingen
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: June 16, 2008
First Posted: July 22, 2008
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:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms