Tinnitus
Conditions
Keywords
tinnitus, biofeedback, psychophysiological reactivity, intervention
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.
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.
Interventions
BEHAVIORALBiofeedback-based cognitive-behavioural intervention
Sponsors
German Research Foundation
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus Questionnaire German Version | — |
| Tinnitus diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Illness perception questionnaire | — |
| Symptom Check List | — |
| Generalized self efficacy | — |
| Pain disability index | — |
| Beck Depression Inventory | — |
Countries
Germany
Outcome results
None listed