Mindfulness-based Therapy in Chronic Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01540357
First received: February 22, 2012
Last updated: September 26, 2013
Last verified: September 2013
  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
Behavioral: Treatment after waiting time

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:


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: 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).
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
Treatment was performed after completion of the active arm.
Behavioral: Treatment after waiting time
Treatment was performed after completion of the active arm.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 26, 2013
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 September 29, 2014