Chronic TinnitusNCT01540357
Mindfulness-based Therapy in Chronic Tinnitus
A study testing Mindfulness-based therapy and Treatment after waiting time in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- Mindfulness-based therapy and Treatment after waiting time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic tinnitus (duration ≥ 6 months)
- German speaking
- Subjective tinnitus
Who cannot join
- Instable medical conditions
- Objective tinnitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study
In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.
Read the 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.
- Conditions
- Chronic Tinnitus
- Being tested
- Mindfulness-based therapy, Treatment after waiting time
- Keywords
- mindfulness-based therapy, chronic tinnitus;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based therapyBehavioural
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 timeBehavioural
Treatment was performed after completion of the active arm.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Mindfulness-based therapy |
| Treatment after waiting time | Active comparator | Treatment was performed after completion of the active arm. Receives: Behavioral: Treatment after waiting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)
Measured: Baseline to Week 9
Secondary outcomes (12)
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
Measured: Week 7
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
Measured: Week 9
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
Measured: Week 24
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
Measured: Week 7
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
Measured: Week 9
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
Measured: Week 24
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
Measured: Week 7
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
Measured: Week 9
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
Measured: Week 24
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)
Measured: Week 7
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)
Measured: Week 9
Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, MD, Ph.D., Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540357
- Sponsor's protocol ID
- MBT-TIN
- Status last verified
- Sep 2013
- First submitted
- 22 Feb 2012
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 8175381Kreuzer 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.
PubMed 23186556
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01540357
- Acronym / sponsor ID
- MBT-TIN
- Conditions
- Chronic Tinnitus
- Keywords
- mindfulness-based therapy, chronic tinnitus;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based therapy | Active comparator | Behavioral: Mindfulness-based therapyTreatment 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 | Active comparator | Behavioral: Treatment after waiting timeTreatment was performed after completion of the active arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic tinnitus (duration ≥ 6 months)
- German speaking
- Subjective tinnitus
Key exclusion criteria (2 listed)
- Instable medical conditions
- Objective tinnitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based therapyTreatment 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). | Behavioural | Mindfulness-based therapy |
| Treatment after waiting timeTreatment was performed after completion of the active arm. | Behavioural | Treatment after waiting time |
Primary outcome
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
12 secondary outcomes
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)
Time frame: Week 7
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)
Time frame: Week 9
Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)
Time frame: Week 24
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)
Time frame: Week 7
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)
Time frame: Week 9
Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)
Time frame: Week 24
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)
Time frame: Week 7
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)
Time frame: Week 9
Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)
Time frame: Week 24
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Background: PubMed 8175381Goebel 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 publication: PubMed 23186556Kreuzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, MD, Ph.D. principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based therapy and Treatment after waiting time in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.