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

University Hospital Tuebingen3 sites in 1 country286 target enrollmentOctober 2000

ConditionsTinnitus

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Tinnitus
Sponsor: University Hospital Tuebingen
Enrollment: 286
Locations: 3
Primary Endpoint: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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)

Registry

clinicaltrials.gov

Start Date

October 2000

End Date

November 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital Tuebingen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)

Time Frame: Last session

Secondary Outcomes

Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale(last therapy session)