Psychophysiological Treatment of Chronic Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Biofeedback-based cognitive-behavioural intervention
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, biofeedback, psychophysiological reactivity, intervention
Eligibility 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
Sites / Locations
- Philipps-University Marburg, Faculty of Psychology
Outcomes
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
Full Information
NCT ID
NCT00397007
First Posted
November 7, 2006
Last Updated
September 27, 2017
Sponsor
Philipps University Marburg Medical Center
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00397007
Brief Title
Psychophysiological Treatment of Chronic Tinnitus
Official Title
Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
German Research Foundation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, biofeedback, psychophysiological reactivity, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback-based cognitive-behavioural intervention
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire German Version
Title
Tinnitus diary
Secondary Outcome Measure Information:
Title
Symptom Check List
Title
Beck Depression Inventory
Title
Illness perception questionnaire
Title
Pain disability index
Title
Generalized self efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Philipps-University Marburg, Faculty of Psychology
City
Marburg
ZIP/Postal Code
35032
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16204446
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. doi: 10.1097/01.psy.0000174174.38908.c6.
Results Reference
background
PubMed Identifier
18193350
Citation
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.
Results Reference
result
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 and acceptance]. Verhaltenstherapie 17(4): 220-230, 2007.
Results Reference
result
PubMed Identifier
19045972
Citation
Weise C, Heinecke K, Rief W. Biofeedback-based behavioral treatment for chronic tinnitus: results of a randomized controlled trial. J Consult Clin Psychol. 2008 Dec;76(6):1046-57. doi: 10.1037/a0013811.
Results Reference
derived
PubMed Identifier
18600443
Citation
Weise C, Heinecke K, Rief W. Stability of physiological variables in chronic tinnitus sufferers. Appl Psychophysiol Biofeedback. 2008 Sep;33(3):149-59. doi: 10.1007/s10484-008-9058-x. Epub 2008 Jul 4.
Results Reference
derived
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Psychophysiological Treatment of Chronic Tinnitus
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