Psychophysiological Treatment of Chronic Tinnitus

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00397007
First received: November 7, 2006
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Tinnitus
Behavioral: Biofeedback-based cognitive-behavioural intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-Based Cognitive-Behavioral Psychotherapy for Chronic Tinnitus-Sufferers

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Tinnitus Questionnaire German Version
  • Tinnitus diary

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

Estimated Enrollment: 130
Study Start Date: May 2005
Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397007

Locations
Germany
Philipps-University Marburg, Faculty of Psychology
Marburg, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
German Research Foundation
Investigators
Study Director: Winfried Rief Philipps University Marburg Medical Center
  More Information

Publications:
Weise, C, Heinecke, K, & Rief, W . Biofeedback bei chronischem Tinnitus - Behandlungsleitfaden und vorläufige Ergebnisse zu Wirksamkeit und Akzeptanz [Biofeedback for chronic tinnitus - Treatment guidelines and preliminary results regarding their efficacy and acceptance]. Verhaltenstherapie 17(4): 220-230, 2007.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00397007     History of Changes
Other Study ID Numbers: RI 574/12-1
Study First Received: November 7, 2006
Last Updated: May 8, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
tinnitus
biofeedback
psychophysiological reactivity
intervention

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014