Mindfulness-based Therapy in Chronic Tinnitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Tinnitus

Intervention / Treatment
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* Behavioral: Mindfulness-based therapy
* Behavioral: Treatment after waiting time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic tinnitus (duration ≥ 6 months) German speaking Subjective tinnitus Exclusion Criteria: Instable medical conditions Objective tinnitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness-based therapy<br>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<br>* 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).<br>|
| Active Comparator: Treatment after waiting time<br>Treatment was performed after completion of the active arm. | Behavioral: Treatment after waiting time<br>* Treatment was performed after completion of the active arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 9) |  | Week 9 | 
| 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 7) |  | Week 7 | 
| Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9) |  | Week 9 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness-based therapy, chronic tinnitus;