Mindfulness-based Therapy in Chronic Tinnitus

Chronic Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540357
• Other study ID #: MBT-TIN
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: September 26, 2013
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: September 2013
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic tinnitus (duration = 6 months)

• German speaking

• Subjective tinnitus

Exclusion Criteria:

• Instable medical conditions

• Objective tinnitus

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Behavioral:
• 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 was performed after completion of the active arm.

Locations

Country	Name	City	State
Germany	University of Regensburg - Dep. of Psychiatry	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)		Baseline to Week 9	No
Secondary	Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)		Week 7	No
Secondary	Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)		Week 9	No
Secondary	Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)		Week 24	No
Secondary	Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)		Week 7	No
Secondary	Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)		Week 9	No
Secondary	Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)		Week 24	No
Secondary	Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)		Week 7	No
Secondary	Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)		Week 9	No
Secondary	Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)		Week 24	No
Secondary	Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)		Week 7	No
Secondary	Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)		Week 9	No
Secondary	Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)		Week 24	No