NCT00397007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

First QC Date

November 7, 2006

Last Update Submit

September 27, 2017

Conditions

Tinnitus

Keywords

tinnitusbiofeedbackpsychophysiological reactivityintervention

Outcome Measures

Primary Outcomes (2)

  • Tinnitus Questionnaire German Version

  • Tinnitus diary

Secondary Outcomes (5)

  • Symptom Check List

  • Beck Depression Inventory

  • Illness perception questionnaire

  • Pain disability index

  • Generalized self efficacy

Interventions

Biofeedback-based cognitive-behavioural interventionBEHAVIORAL

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with distressing and chronic tinnitus (for at least 6 month)
  • age: 16-75 years
  • sufficient language skills
  • plus
  • healthy control-subjects
  • without tinnitus or other hearing disease

You may not qualify if:

  • tinnitus as a result of medical disease (e.g.Meniere's disease)
  • attendance in the previous study
  • psychosis or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps-University Marburg, Faculty of Psychology

Marburg, 35032, Germany

Location

Related Publications (5)

  • 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.

    PMID: 16204446BACKGROUND

  • 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.

    PMID: 18193350RESULT

  • 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.

    RESULT

  • 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.

    PMID: 19045972DERIVED

  • 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.

    PMID: 18600443DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Winfried Rief

    Philipps University Marburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

May 1, 2005

Study Completion

May 1, 2008

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

DE(1)