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CompletedNCT01540357Updated Sep 27, 2013

Mindfulness-based Therapy in Chronic Tinnitus

An interventional study of Mindfulness-based therapy and Treatment after waiting time in Chronic Tinnitus, sponsored by University of Regensburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Chronic Tinnitus

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Keywords

  • mindfulness-based therapy
  • chronic tinnitus;
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In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Instable medical conditions
  • Objective tinnitus
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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

  • Active comparator
    Treatment after waiting time

    Treatment was performed after completion of the active arm.

    Behavioral: Treatment after waiting time

Interventions

  • BehavioralMindfulness-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).

  • BehavioralTreatment after waiting time

    Treatment was performed after completion of the active arm.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)

    Time frame: Week 7

  2. Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)

    Time frame: Week 9

  3. Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)

    Time frame: Week 24

  4. Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)

    Time frame: Week 7

  5. Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)

    Time frame: Week 9

  6. Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)

    Time frame: Week 24

  7. Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)

    Time frame: Week 7

  8. Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)

    Time frame: Week 9

  9. Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)

    Time frame: Week 24

  10. 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

  11. 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

  12. 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

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Study locations

1 site
  • University of Regensburg - Dep. of Psychiatry
    Regensburg, 93153, Germany
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References and documents

Publications

  • Goebel G, Hiller W. [The tinnitus questionnaire. A standard instrument for grading the degree of tinnitus. Results of a multicenter study with the tinnitus questionnaire]. HNO. 1994 Mar;42(3):166-72. German. PubMed 8175381 ↗
  • Kreuzer PM, Goetz M, Holl M, Schecklmann M, Landgrebe M, Staudinger S, Langguth B. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study. BMC Complement Altern Med. 2012 Nov 28;12:235. doi: 10.1186/1472-6882-12-235. PubMed 23186556 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01540357
Lead sponsor
University of Regensburg
Responsible party
Berthold Langguth, MD, Ph.D. (Principal Investigator, University of Regensburg) — Principal investigator
First posted
Feb 28, 2012
Start date
May 2010
Primary completion
Oct 2010
Completion
Jan 2012
Last update
Sep 27, 2013

Study contacts

Berthold Langguth, MD, Ph.D.
principal investigator · University of Regensburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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