Mindfulness-based Therapy in Chronic Tinnitus

NCT01540357 | Completed

• 1 other identifier: MBT-TIN
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tinnitus

Keywords

mindfulness-based therapy; chronic tinnitus;

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 9

Secondary Outcomes (12)

• Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)

  Week 7

• Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)

  Week 9

• Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)

  Week 24

• Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)

  Week 7

• Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)

  Week 9

Study Arms (2)

Mindfulness-based therapy

ACTIVE COMPARATOR

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 after waiting time

ACTIVE COMPARATOR

Treatment was performed after completion of the active arm.

Behavioral: Treatment after waiting time

Interventions

Mindfulness-based therapy BEHAVIORAL

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).

Mindfulness-based therapy

Treatment after waiting time BEHAVIORAL

Treatment was performed after completion of the active arm.

Treatment after waiting time

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Instable medical conditions
• Objective tinnitus

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University of Regensburg - Dep. of Psychiatry

Regensburg, 93153, Germany

Location

Related 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.

  PMID: 8175381 BACKGROUND

• 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.

  PMID: 23186556 RESULT

Study Officials

• Berthold Langguth, MD, Ph.D.

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 28, 2012
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2012
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

DE (1)