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TCP: Tinnitus Treatment by Structured Cognitive Behavioral Therapy

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT00719940
Collaborator
(none)
286
Enrollment
4
Locations
2
Arms
73
Duration (Months)
71.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy
  • Other: Waiting group
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
286 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Cognitive behavioral therapy

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 Names:
  • tinnitus care program

    		•
    Placebo Comparator: 2

    Waiting group

    Other: Waiting group
    No intervention
    Other Names:
  • tinnitus care program

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) [Last session]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tinnitus Care Center Aschaffenburg Germany 63739
    2 Tinnitus Care Center Frankfurt Germany 60594
    3 Dept. ORL, University of Tuebingen Tuebingen Germany 72070
    4 Private Practice Tuebingen Germany 72070

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    • Principal Investigator: Hans P. Zenner, M.D., Universität Tübingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00719940
    Other Study ID Numbers:
    • TCP00/04
    • BMBF 01EZ0506: Dekonet;
    • Mediceon: Benchmarking project
    First Posted:
    Jul 22, 2008
    Last Update Posted:
    Jul 22, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    tinnitus, cognitive behavioral therapy, CBT
    Additional relevant MeSH terms:
    Tinnitus

    Study Results

    No Results Posted as of Jul 22, 2008