Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397007
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2006-11-07
Brief Title:
Psychophysiological Treatment of Chronic Tinnitus
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None