NCT02632058

Brief Summary

Tinnitus is the acoustic perception of sound without any physical source. It is estimated that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation in all aspects of daily life of the affected. There is currently no evidence for a successful treatment of tinnitus. While one treatment approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment aspect in our setting involved cognitive behavioural therapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Status
unknown

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

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

December 14, 2015

Last Update Submit

December 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998).

    6-8 weeks

Secondary Outcomes (3)

  • Brief Symptom Inventory (BSI, Derogatis 1975)

    6-8 weeks

  • Beck Depression Inventory (BDI, Beck 1961)

    6-8 weeks

  • Noise Sensitivity Questionnaire [Nelting 2004]

    6-8 weeks

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients suffering from chronic tinnitus referred to our clinic by their treating physician. There is a remarkable level of suffering from chronic tinnitus in these individuals. The participants received an established routine treatment as part of multimodal treatment at an inpatient psychiatric facility. Clinical experience shows that the applied treatment poses a low risk and demonstrates a great amount of benefit. At admission to our clinic all participants were of age and able to give their consent to treatment.

You may qualify if:

  • minimum age of 18,
  • existing Tinnitus auris or capitis

You may not qualify if:

  • Psychosis,
  • serious physical illness,
  • Organic psychiatric disability (ICD-10 F0x.x),
  • diseases classified under ICD-10 F2x.x,
  • Lack of capacity,
  • current substance abuse (F10.x - F19.x according to ICD-10, F17.x not included),
  • insufficient knowledge of German.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 16, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

December 16, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share