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Mindfulness-based Therapy in Chronic Tinnitus

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness-based therapy
Treatment after waiting time
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus focused on measuring mindfulness-based therapy, chronic tinnitus;

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Instable medical conditions
  • Objective tinnitus

Sites / Locations

  • University of Regensburg - Dep. of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness-based therapy

Treatment after waiting time

Arm Description

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 was performed after completion of the active arm.

Outcomes

Primary Outcome Measures

Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)

Secondary Outcome Measures

Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)

Full Information

First Posted
February 22, 2012
Last Updated
September 26, 2013
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01540357
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
mindfulness-based therapy, chronic tinnitus;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Treatment after waiting time
Arm Type
Active Comparator
Arm Description
Treatment was performed after completion of the active arm.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment after waiting time
Intervention Description
Treatment was performed after completion of the active arm.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
Time Frame
Week 7
Title
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
Time Frame
Week 9
Title
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
Time Frame
Week 24
Title
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
Time Frame
Week 7
Title
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
Time Frame
Week 9
Title
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
Time Frame
Week 24
Title
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
Time Frame
Week 7
Title
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
Time Frame
Week 9
Title
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
Time Frame
Week 24
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic tinnitus (duration ≥ 6 months) German speaking Subjective tinnitus Exclusion Criteria: Instable medical conditions Objective tinnitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, Ph.D.
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Dep. of Psychiatry
City
Regensburg
ZIP/Postal Code
93153
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
8175381
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.
Results Reference
background
PubMed Identifier
23186556
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.
Results Reference
result

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Mindfulness-based Therapy in Chronic Tinnitus

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