Tinnitus Treatment by Structured Cognitive Behavioral Therapy - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00719940

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 IV

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

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
1: Experimental 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
2: Placebo Comparator Waiting group	Other: Waiting group No intervention

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
Dept. ORL, University of Tuebingen
Tuebingen, Germany, 72070
Private Practice
Tuebingen, Germany, 72070
Tinnitus Care Center
Frankfurt, Germany, 60594
Tinnitus Care Center
Aschaffenburg, Germany, 63739

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Hans P. Zenner, M.D.

University of Tuebingen, Germany

More Information

Principal Investigator´s site This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	University Hospital, University of Tuebingen, Germany ( Zenner, H.P., M.D., Professor & Chairman, Dept. ORL, University of Tuebingen, Germany )
Study ID Numbers:	TCP00/04, BMBF 01EZ0506: Dekonet;, Mediceon: Benchmarking project
Study First Received:	June 16, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00719940
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:

tinnitus, cognitive behavioral therapy, CBT

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009