Psychophysiological Treatment of Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Biofeedback-based cognitive-behavioural intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: tinnitus; biofeedback; psychophysiological reactivity; intervention