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Completed

NCT Number: NCT00397007

Psychophysiological Treatment of Chronic Tinnitus

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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Philipps-University Marburg, Faculty of Psychology

Marburg, 35032, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback-based cognitive-behavioural intervention

Behavioral

Primary outcomes

  1. Tinnitus Questionnaire German Version

  2. Tinnitus diary

Secondary outcomes

  1. Symptom Check List

  2. Beck Depression Inventory

  3. Illness perception questionnaire

  4. Pain disability index

  5. Generalized self efficacy

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2008
First posted
Nov 8, 2006
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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