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Completed

NCT Number: NCT01540357

Mindfulness-based Therapy in Chronic Tinnitus

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

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Key information

Conditions

Chronic Tinnitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg - Dep. of Psychiatry

Regensburg, 93153, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Instable medical conditions
  • Objective tinnitus

Treatment and study plan

Mindfulness-Based Therapy

Behavioral

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).

Treatment after waiting time

Behavioral

Treatment was performed after completion of the active arm.

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

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Feb 28, 2012
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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