Tinnitus Treatment by Structured Cognitive Behavioral Therapy

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Other: Waiting group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive behavioral therapy | Behavioral: Cognitive behavioral therapy<br>* 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<br>* Other names: tinnitus care program;|
| Placebo Comparator: 2<br>Waiting group | Other: Waiting group<br>* No intervention<br>* Other names: tinnitus care program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) |  | Last session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale |  | last therapy session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, cognitive behavioral therapy, CBT