Tinnitus Treatment by Structured Cognitive Behavioral Therapy (TCP)

University Hospital Tuebingen

Status and phase: Completed; Phase 4

Conditions: Tinnitus

Treatments: Other: Waiting group; Behavioral: Cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00719940

TCP00/04

Mediceon: Benchmarking project

BMBF 01EZ0506: Dekonet ;

Details and patient eligibility

About

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.

Full 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)

Enrollment: 286 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Cognitive behavioral therapy

Treatment:

Behavioral: Cognitive behavioral therapy

2

Placebo Comparator group

Description:

Waiting group

Treatment:

Other: Waiting group