Tinnitus Treatment by Structured Cognitive Behavioral Therapy
TCP
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
3 other identifiers
interventional
286
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2000
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 22, 2008
CompletedJuly 22, 2008
June 1, 2008
4 years
June 16, 2008
July 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
Last session
Secondary Outcomes (1)
Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale
last therapy session
Study Arms (2)
1
EXPERIMENTALCognitive behavioral therapy
2
PLACEBO COMPARATORWaiting group
Interventions
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
Eligibility Criteria
You may qualify if:
- Persistent and stable tinnitus of more than 11 weeks
- Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale
You may not qualify if:
- Psychiatric or neurological comorbidity
- Tinnitus as concomitant symptom of an otherwise treatable disease
- Drug treatment for tinnitus 24 hrs. prior or during therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tinnitus Care Center
Aschaffenburg, 63739, Germany
Tinnitus Care Center
Frankfurt, 60594, Germany
Dept. ORL, University of Tuebingen
Tübingen, 72070, Germany
Private Practice
Tübingen, 72070, Germany
Related Publications (2)
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.
PMID: 16353397RESULTZenner 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.
PMID: 23287811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans P. Zenner, M.D.
Universität Tübingen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2008
First Posted
July 22, 2008
Study Start
October 1, 2000
Primary Completion
October 1, 2004
Study Completion
November 1, 2006
Last Updated
July 22, 2008
Record last verified: 2008-06