Tinnitus Treatment by Structured Cognitive Behavioral Therapy

Tinnitus Clinical Trial

— TCP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719940
• Other study ID #: TCP00/04
• Secondary ID: BMBF 01EZ0506: D
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2008
• Last updated: July 18, 2008
• Start date: October 2000
• Est. completion date: November 2006

Study information

• Verified date: June 2008
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: November 2006
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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:
• Waiting group
No intervention

Locations

Country	Name	City	State
Germany	Tinnitus Care Center	Aschaffenburg
Germany	Tinnitus Care Center	Frankfurt
Germany	Dept. ORL, University of Tuebingen	Tuebingen
Germany	Private Practice	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)		Last session	Yes
Secondary	Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale		last therapy session	Yes