Mindfulness-based Therapy in Chronic Tinnitus

September 26, 2013 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study

In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the current randomized waiting-list-controlled pilot study, we investigate a new manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and which has been specifically developed for the treatment of tinnitus patients (Tinnitus Atemtherapie; http://www.maria-holl.de/). Essential components of the treatment program include mindfulness, meditation, selfmassage, and breathing exercises. These components are intended to help patients use their inner resources to accept responsibility for themselves, become more self-sufficient and develop symptom acceptance.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93153
        • University of Regensburg - Dep. of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic tinnitus (duration ≥ 6 months)
  • German speaking
  • Subjective tinnitus

Exclusion Criteria:

  • Instable medical conditions
  • Objective tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness-based therapy
Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).
Behavioral: Mindfulness-based therapy
Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).
Active Comparator: Treatment after waiting time
Treatment was performed after completion of the active arm.
Behavioral: Treatment after waiting time
Treatment was performed after completion of the active arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)
Time Frame: Baseline to Week 9
Baseline to Week 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
Time Frame: Week 7
Week 7
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
Time Frame: Week 9
Week 9
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
Time Frame: Week 24
Week 24
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
Time Frame: Week 7
Week 7
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
Time Frame: Week 9
Week 9
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
Time Frame: Week 24
Week 24
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
Time Frame: Week 7
Week 7
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
Time Frame: Week 9
Week 9
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
Time Frame: Week 24
Week 24
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)
Time Frame: Week 7
Week 7
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)
Time Frame: Week 9
Week 9
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Berthold Langguth, MD, Ph.D., University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBT-TIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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