Mindfulness-based Therapy in Chronic Tinnitus

Not Applicable

Completed

• Conditions: Chronic Tinnitus
• Interventions: Behavioral: Mindfulness-based therapy; Behavioral: Treatment after waiting time

• Registration Number: NCT01540357
• Lead Sponsor: University of Regensburg

Brief 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.

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2010-10
• Study Completion: 2012-01
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

• Instable medical conditions
• Objective tinnitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based therapy	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).
Treatment after waiting time	Treatment after waiting time	Treatment was performed after completion of the active arm.

Primary Outcome Measures

Name	Time	Method
Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)	Baseline to Week 9

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Regensburg - Dep. of Psychiatry; 🇩🇪 Regensburg, Germany