Clinical trial NCT01540357: Mindfulness-based Therapy in Chronic Tinnitus
Official title: Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: mindfulness-based therapy
chronic tinnitus;
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Instable medical conditions
* Objective tinnitus

Primary outcomes:
measure: Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)
timeFrame: Baseline to Week 9
Secondary outcomes:
measure: Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
timeFrame: Week 7
measure: Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
timeFrame: Week 9
measure: Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
timeFrame: Week 24
measure: Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
timeFrame: Week 7
measure: Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
timeFrame: Week 9
measure: Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
timeFrame: Week 24
measure: Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
timeFrame: Week 7
measure: Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
timeFrame: Week 9
measure: Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
timeFrame: Week 24
measure: Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)
timeFrame: Week 7
measure: Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)
timeFrame: Week 9
measure: Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)
timeFrame: Week 24
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg - Dep. of Psychiatry
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.