Tinnitus Treatment by Structured Cognitive Behavioral Therapy

NCT ID: NCT00719940

Last Updated: 2008-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Tinnitus

Keywords

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tinnitus, cognitive behavioral therapy, CBT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cognitive behavioral therapy

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

Waiting group

Group Type PLACEBO_COMPARATOR

Waiting group

Intervention Type OTHER

No intervention

Interventions

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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

Intervention Type BEHAVIORAL

Waiting group

No intervention

Intervention Type OTHER

Other Intervention Names

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tinnitus care program tinnitus care program

Eligibility Criteria

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Inclusion Criteria

* Persistent and stable tinnitus of more than 11 weeks
* Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, University of Tuebingen, Germany

Principal Investigators

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Hans P. Zenner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universität Tübingen

Locations

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Tinnitus Care Center

Aschaffenburg, , Germany

Site Status

Tinnitus Care Center

Frankfurt, , Germany

Site Status

Dept. ORL, University of Tuebingen

Tübingen, , Germany

Site Status

Private Practice

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1080/00016480510012282.

Reference Type RESULT
PMID: 16353397 (View on PubMed)

Zenner HP, Vonthein R, Zenner B, Leuchtweis R, Plontke SK, Torka W, Pogge S, Birbaumer N. Standardized tinnitus-specific individual cognitive-behavioral therapy: a controlled outcome study with 286 tinnitus patients. Hear Res. 2013 Apr;298:117-25. doi: 10.1016/j.heares.2012.11.013. Epub 2012 Dec 31.

Reference Type DERIVED
PMID: 23287811 (View on PubMed)

Other Identifiers

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BMBF 01EZ0506: Dekonet;

Identifier Type: -

Identifier Source: secondary_id

Mediceon: Benchmarking project

Identifier Type: -

Identifier Source: secondary_id

TCP00/04

Identifier Type: -

Identifier Source: org_study_id