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Sponsors and Collaborators: |
Philipps University Marburg Medical Center German Research Foundation |
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Information provided by: | Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT00397007 |
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 |
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 |
Estimated Enrollment: | 130 |
Study Start Date: | May 2005 |
Study Completion Date: | May 2008 |
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.
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
plus
Exclusion Criteria (for both):
Germany | |
Philipps-University Marburg, Faculty of Psychology | |
Marburg, Germany, 35032 |
Study Director: | Winfried Rief | Philipps University Marburg Medical Center |
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 |
tinnitus biofeedback psychophysiological reactivity intervention |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Neurologic Manifestations Ear Diseases Tinnitus |
Nervous System Diseases |