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Psychophysiological Treatment of Chronic Tinnitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397007
First Posted: November 8, 2006
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
November 7, 2006
November 8, 2006
October 2, 2017
May 2005
Not Provided
  • Tinnitus Questionnaire German Version
  • Tinnitus diary
Same as current
Complete list of historical versions of study NCT00397007 on ClinicalTrials.gov Archive Site
  • Symptom Check List
  • Beck Depression Inventory
  • Illness perception questionnaire
  • Pain disability index
  • Generalized self efficacy
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Tinnitus
Behavioral: Biofeedback-based cognitive-behavioural intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
May 2008
Not Provided

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
Sexes Eligible for Study: All
16 Years to 75 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00397007
RI 574/12-1
Not Provided
Not Provided
Not Provided
Winfried Rief, Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
German Research Foundation
Study Director: Winfried Rief Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP