Study 15 of 33 for search of: "Tinnitus"
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Psychophysiological Treatment of Chronic Tinnitus
This study has been completed.
Sponsors and Collaborators: Philipps University Marburg Medical Center
German Research Foundation
Information provided by: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00397007
  Purpose

The study aims to develop and to evaluate a psychophysiological intervention for distressing chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned to either an intervention-group, receiving 12 sessions of a psychophysiological oriented intervention, or to a waiting-list-group, who are waiting for a comparable time period. Afterwards, patients of the waiting-list-group also receive intervention. The effects of the intervention on severity, distress and perceived loudness of the tinnitus as well as on other psychological variables like depression or self-efficacy are evaluated through comparing the results of the intervention group with those of the waiting-list-group.

Additionally the psychophysiological reactivity under different stress-conditions is measured before and after intervention or waiting. Therefore the activity of the muscles of head and shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is hypothesized that patients with stronger psychophysiological reactivity benefit more from an psychophysiological intervention.


Condition Intervention Phase
Tinnitus
Behavioral: Biofeedback-based cognitive-behavioural intervention
Phase II

MedlinePlus related topics: Depression Tinnitus Toe Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-Based Cognitive-Behavioral Psychotherapy for Chronic Tinnitus-Sufferers

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Tinnitus Questionnaire German Version
  • Tinnitus diary

Secondary Outcome Measures:
  • Symptom Check List
  • Beck Depression Inventory
  • Illness perception questionnaire
  • Pain disability index
  • Generalized self efficacy

Estimated Enrollment: 130
Study Start Date: May 2005
Study Completion Date: May 2008
Detailed Description:

The study aims to develop and to evaluate a psychophysiological intervention for distressing chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned to either an intervention-group, receiving 12 sessions of a psychophysiological oriented intervention, or to a waiting-list-group, who are waiting for a comparable time period. Afterwards, patients of the waiting-list-group also receive intervention. The effects of the intervention on severity, distress and perceived loudness of the tinnitus as well as on other psychological variables like depression or self-efficacy are evaluated through comparing the results of the intervention group with those of the waiting-list-group.

Additionally the psychophysiological reactivity under different stress-conditions is measured before and after intervention or waiting. Therefore the activity of the muscles of head and shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is hypothesized that patients with stronger psychophysiological reactivity benefit more from an psychophysiological intervention.

Further aims of the study are 1) to compare the muscle activity of the tinnitus-patients with those from healthy controls, because till now no study investigated if tinnitus-patients effectively present higher muscle activity in head and shoulders than healthy people and 2) to evaluate the influence of the subjective illness perceptions on the intervention-outcome, because it is hypothesized that patients with more somatic illness perceptions benefit more from a psychophysiological intervention than patients with rather psychological illness perceptions.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 100 subjects with distressing and chronic tinnitus (for at least 6 month)
  • age: 16-75 years
  • sufficient language skills

plus

  • 50 healthy control-subjects
  • without tinnitus or other hearing disease

Exclusion Criteria (for both):

  • tinnitus as a result of medical disease (e.g.Meniere's disease)
  • attendance in the previous study
  • psychosis or dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397007

Locations
Germany
Philipps-University Marburg, Faculty of Psychology
Marburg, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
German Research Foundation
Investigators
Study Director: Winfried Rief Philipps University Marburg Medical Center
  More Information

Publications of Results:
Other Publications:
Publications indexed to this study:
Study ID Numbers: RI 574/12-1
Study First Received: November 7, 2006
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00397007  
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
tinnitus
biofeedback
psychophysiological reactivity
intervention

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009