Skip to main content
Clinical Trials/NCT00397007
NCT00397007
Completed
Phase 2

Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers

Philipps University Marburg Medical Center1 site in 1 country130 target enrollmentMay 2005
ConditionsTinnitus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tinnitus
Sponsor
Philipps University Marburg Medical Center
Enrollment
130
Locations
1
Primary Endpoint
Tinnitus Questionnaire German Version
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
May 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winfried Rief

Professor Dr.

Philipps University Marburg Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Tinnitus Questionnaire German Version

Tinnitus diary

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials