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Completed

NCT Number: NCT00719940

Tinnitus Treatment by Structured Cognitive Behavioral Therapy

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.

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Key information

Conditions

Tinnitus Color Vision Defects Cone Dystrophy Ear Diseases Eye Diseases Eye Diseases, Hereditary Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tinnitus Care Center, Aschaffenburg, Germany

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Waiting Group

Other

No intervention

Other names: tinnitus care program

Primary outcomes

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

    Time frame: 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

    Time frame: last therapy session

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Acronym: TCP

Important dates

Study start
2000
Primary completion
2004
Study completion
2006
First posted
Jul 22, 2008
Registry last updated
Jul 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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