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Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Waiting group
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, cognitive behavioral therapy, CBT

Eligibility Criteria

14 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tinnitus Care Center
  • Tinnitus Care Center
  • Dept. ORL, University of Tuebingen
  • Private Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Cognitive behavioral therapy

Waiting group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2008
Last Updated
July 18, 2008
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00719940
Brief Title
Tinnitus Treatment by Structured Cognitive Behavioral Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, cognitive behavioral therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Waiting group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Other Intervention Name(s)
tinnitus care program
Intervention Description
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
Other
Intervention Name(s)
Waiting group
Other Intervention Name(s)
tinnitus care program
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
Time Frame
Last session
Secondary Outcome Measure Information:
Title
Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale
Time Frame
last therapy session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans P. Zenner, M.D.
Organizational Affiliation
Universität Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tinnitus Care Center
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Tinnitus Care Center
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Dept. ORL, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72070
Country
Germany
Facility Name
Private Practice
City
Tuebingen
ZIP/Postal Code
72070
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16353397
Citation
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.
Results Reference
result
PubMed Identifier
23287811
Citation
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.
Results Reference
derived

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Tinnitus Treatment by Structured Cognitive Behavioral Therapy

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