Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00719940
First received: June 16, 2008
Last updated: July 18, 2008
Last verified: June 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
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 September 22, 2014