Psychophysiological Treatment of Chronic Tinnitus | NCT00397007

Studies
Psychophysiological Treatment of Chronic Tinnitus

NCT00397007

Sponsor

Philipps University Marburg

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

130Estimated

Phase

Phase 2

Conditions

Tinnitus

Interventions

Biofeedback-based cognitive-behavioural intervention

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Nov 7, 2006

First Submission Date that Met QC Criteria

Nov 7, 2006

First Posted Date

Nov 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Oct 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Winfried Rief, Professor Dr., Philipps University MarburgPrincipal Investigator

Lead Sponsor

Philipps University MarburgOTHER

Collaborators

Name	Class
German Research Foundation	OTHER

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Name	Type	Description	Arm Group Labels	Other Names
Biofeedback-based cognitive-behavioural intervention	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tinnitus Questionnaire German Version
Tinnitus diary

Secondary Outcomes

Measure	Description	Time Frame
Symptom Check List
Beck Depression Inventory
Illness perception questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried Rief	Philipps University Marburg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Philipps-University Marburg, Faculty of Psychology		Marburg		35032	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16204446	Background	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.
18193350	Result	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.

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders