- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397007
Psychophysiological Treatment of Chronic Tinnitus
Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Marburg, Germany, 35032
- Philipps-University Marburg, Faculty of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Tinnitus Questionnaire German Version
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Tinnitus diary
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Secondary Outcome Measures
Outcome Measure |
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Beck Depression Inventory
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Symptom Check List
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Illness perception questionnaire
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Pain disability index
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Generalized self efficacy
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Winfried Rief, Philipps University Marburg Medical Center
Publications and helpful links
General Publications
- Rief W, Weise C, Kley N, Martin A. Psychophysiologic treatment of chronic tinnitus: a randomized clinical trial. Psychosom Med. 2005 Sep-Oct;67(5):833-8. doi: 10.1097/01.psy.0000174174.38908.c6.
- Heinecke K, Weise C, Schwarz K, Rief W. Physiological and psychological stress reactivity in chronic tinnitus. J Behav Med. 2008 Jun;31(3):179-88. doi: 10.1007/s10865-007-9145-0. Epub 2008 Jan 12.
- Weise, C, Heinecke, K, & Rief, W . Biofeedback bei chronischem Tinnitus - Behandlungsleitfaden und vorläufige Ergebnisse zu Wirksamkeit und Akzeptanz [Biofeedback for chronic tinnitus - Treatment guidelines and preliminary results regarding their efficacy and acceptance]. Verhaltenstherapie 17(4): 220-230, 2007.
- Weise C, Heinecke K, Rief W. Biofeedback-based behavioral treatment for chronic tinnitus: results of a randomized controlled trial. J Consult Clin Psychol. 2008 Dec;76(6):1046-57. doi: 10.1037/a0013811.
- Weise C, Heinecke K, Rief W. Stability of physiological variables in chronic tinnitus sufferers. Appl Psychophysiol Biofeedback. 2008 Sep;33(3):149-59. doi: 10.1007/s10484-008-9058-x. Epub 2008 Jul 4.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RI 574/12-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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