Mindfulness-based Therapy in Chronic Tinnitus - Full Text View

Purpose

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

Condition	Intervention
Chronic Tinnitus	Behavioral: Mindfulness-based therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by University of Regensburg:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7) [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7) [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7) [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	May 2010
Study Completion Date:	January 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Immediate treatment Patients were randomized to receive treatment immediately.	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).
Active Comparator: Treatment after waiting time Patients were randomized to receive treatment after waiting time, which served as control condition.	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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Instable medical conditions
Objective tinnitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540357

Locations

Germany
University of Regensburg - Dep. of Psychiatry
Regensburg, Germany, 93153

Sponsors and Collaborators

University of Regensburg

Investigators

Principal Investigator:

Berthold Langguth, MD, Ph.D.

University of Regensburg

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Berthold Langguth, MD, Ph.D., Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier:	NCT01540357 History of Changes
Other Study ID Numbers:	MBT-TIN
Study First Received:	February 22, 2012
Last Updated:	February 27, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:

mindfulness-based therapy
chronic tinnitus;

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013