Psychophysiological Treatment of Chronic Tinnitus

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397007
• Other study ID #: RI 574/12-1
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2006
• Last updated: September 27, 2017
• Start date: May 2005
• Est. completion date: May 2008

Study information

• Verified date: September 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Biofeedback-based cognitive-behavioural intervention

Locations

Country	Name	City	State
Germany	Philipps-University Marburg, Faculty of Psychology	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Heinecke K, Weise C, Schwarz K, Rief W. Physiological and psychological stress reactivity in chronic tinnitus. J Behav Med. 2008 Jun;31(3):179-88. doi: 10.1007/s10865-007-9145-0. Epub 2008 Jan 12. — View Citation

Rief W, Weise C, Kley N, Martin A. Psychophysiologic treatment of chronic tinnitus: a randomized clinical trial. Psychosom Med. 2005 Sep-Oct;67(5):833-8. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Questionnaire German Version
Primary	Tinnitus diary
Secondary	Symptom Check List
Secondary	Beck Depression Inventory
Secondary	Illness perception questionnaire
Secondary	Pain disability index
Secondary	Generalized self efficacy