Tinnitus Treatment by Structured Cognitive Behavioral Therapy

Phase 4

Completed

• Conditions: Tinnitus
• Interventions: Behavioral: Cognitive behavioral therapy; Other: Waiting group

• Registration Number: NCT00719940
• Lead Sponsor: University Hospital Tuebingen

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)

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2004-10
• Study Completion: 2006-11
• Status Verified: 2008-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-07-18
• Last Update Submitted: 2008-07-18
• Study First Posted: 2008-07-22
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive behavioral therapy	Cognitive behavioral therapy
2	Waiting group	Waiting group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Private Practice; 🇩🇪 Tuebingen, Germany

Tinnitus Care Center; 🇩🇪 Frankfurt, Germany

Dept. ORL, University of Tuebingen; 🇩🇪 Tuebingen, Germany