Wetenschappelijk onderzoek naar TAT, Regensburg en GESOMED

foto van handen en koraalDe TAT-methode is in een wetenschappelijke pilot aan de universiteit van Regensburg gerandomiseerd onderzocht. Bij de proefpersonen is toen een verbetering van 50 % geconstateerd. 80% van de deelnemers kon na afloop beter omgaan met de psychische belasting van hun tinnitus.  U kunt het verslag hiervan vinden via:
http://www.biomedcentral.com/1472-6882/12/235 

Uit het rapport naar aanleiding van het wetenschappelijk onderzoek:

Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

Peter M Kreuzer*Monika GoetzMaria HollMartin SchecklmannMichael Landgrebe,Susanne Staudinger and Berthold Langguth

Background

Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus.

Methods

Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22). Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ).

Results

ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010). Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p < 0.001; control group: t = 2.5; df = 16; p = 0.023), but the intervention group improved more than the control group. Groups differed at week 7 and 9, but not at week 24 as far as the TQ score was concerned.

Conclusions

Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes.

The study is registered with clinicaltrials.gov (NCT01540357).

Keywords: 

Subjective tinnitus; Mindfulness-based therapy; Somatoform disorders; Self-management

Background

Tinnitus is defined as the perception of sound in the absence of an external sound source. About one in 10 adults is affected by chronic tinnitus, 20–30 percent of them dealing with considerable effects on daily living  Severe tinnitus is frequently related to comorbidities such as insomnia, somatoform disorders, depression  or anxiety . There have not been many effective treatment options up to now . The best evidence is available for cognitive behavioral therapy so far, which aims to facilitate habituation by improving individual tinnitus coping strategies .

Mindfulness-based approaches use meditation techniques and yoga-like elements, and were introduced to clinical medicine about thirty years ago. They have demonstrated efficacy in the treatment of a variety of stress-related disorders  such as anxiety and mood disorders or chronic pain. Very recently, mindfulness-based cognitive therapy has been proposed for the treatment of tinnitus. Mindfulness also constitutes an integral element of the cognitive behavioral treatment programs for tinnitus that have shown convincing results in this indication so far.

In the current randomized waiting-list-controlled pilot study, we investigated 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). Essential components of the treatment program include mindfulness, meditation, self-massage, 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.

Methods

Patient recruitment

Thirty-six patients with chronic tinnitus (duration ≥ 6 months) were randomized in an experimental group or a waiting list control group of 18 subjects, each after giving written, informed consent to the study. Randomization was conducted applying a computer-generated random list. Clients were recruited by direct referral from a local ENT physician and by an advertisement in the newsletter of the German Tinnitus League. The study was approved by the local ethics committee of the University of Regensburg, Germany (Ethikkommission der Fakultät für Medizin der Universität Regensburg). The study is registered with clinicaltrials.gov (NCT01540357).

Study design

Inclusion criteria were 1) age between 18 and 80 years 2) location in the north-western part of Germany or in Belgium and the ability to understand the German language 3) no communicational problems 4) individual burden caused by subjective tinnitus for at least 6 months and 5) absence of any instable medical conditions. The experimental group was treated with the manualized group therapy; the control group was assessed at the identical time points during a waiting period of 24 weeks before they received treatment. No changes to methods and outcome measures were made after the trial began.

Treatment program

The treatment program includes mindfulness, meditation, self-massage, and breathing exercises as the main components and was developed and manualized  by one of the authors (MH). MH is an experienced therapist with a focus on stress-related disorders and also conducted the therapeutic meetings in Aachen, Germany.

Briefly, the treatment consists of (1) meditation elements, (2) imagination exercises, (3) self-massage and individualized gentle movement exercises of the body, (4) exercises aiming at directing moment-to-moment awareness of body- and self- perception and (5) breathing exercises with emphasis on expiration in order to reduce muscle tension and increase relaxation. Participants were taught the therapeutic modules at two weekends (11 hours of treatment/weekend) with an interval of 7 weeks. Two weeks after each weekend and 11 and 15 weeks after the second training weekend patients gathered for a review meeting lasting 2 hours each. Patients were strongly encouraged to perform exercises themselves regularly and were instructed to contact and motivate each other by telephone at least once a week. Data assessment and analysis took place at the University of Regensburg, Regensburg, Germany.

Assessment instruments and statistical analysis

Tinnitus characteristics were assessed before treatment (baseline), at week 7 (end of second training weekend), at week 9 and week 24 . Tinnitus assessments included the German versions of the Tinnitus Handicap Inventory , the Tinnitus Questionnaire , the Beck Depression Inventory , several tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness). Prospective assessment of treatment effects was performed using standardized procedures as established in the Tinnitus Research Initiative (TRI) database . Data management was conducted according to the Data Handling Plan (TRI-DHP Version 06, May 9th, 2011). Data analysis was conducted according to the Standard Operating Procedure (TRI-SA Version 01, May 9th, 2011), which followed a study-specific Statistical Analysis Plan (SAP-002). All documents are to be found under http://database.tinnitusresearch.org/webcite.

The primary outcome was the change in TQ scores from baseline to week 9. For this purpose, we conducted an analysis of variance (ANOVA) with the within-subjects factor time (screening and week 9) and the between-subjects factor group (intervention vs. control group). Repeated measures ANOVA as used in this study may be confounded with several issues, i.e., low statistical power, regression to the mean due to baseline differences, inflation of type I error due to multiple post hoc tests, etc.  Thus, we controlled for these issues by repeating the primary outcome analysis by calculating an ANCOVA with the between-subjects factor group (intervention vs. control group), with the baseline values of the TQ as covariate, and with TQ score at week 9 as dependent variable. Regression slopes between the covariate and the dependent variable were comparable across conditions (0.848 and 0.864). Secondary outcome measures included chi-square tests for the variables group and treatment response, which was defined as amelioration of at least 5 points in the TQ. In addition, we conducted an additional ANOVA with the factor group and time, this time including four measurement time points (screening, week7, week 9, and week 24). For THI, the numeric rating scales and BDI we performed identical ANOVAs.

Results

The trial was conducted and terminated according to the study protocol priorily defined. No adaption was necessary during the course of the study (April 2010 to December 2010).

We are well aware of the limiting factors of the pilot study conducted, such as the small sample size, the inherent problems of waiting-list control conditions , and the fact that treatment effects may depend on the instructor, which might limit generalization of the results. Nevertheless our pilot data indicate the promise of mindfulness- and body-psychotherapy-based therapy in the treatment of tinnitus and warrant further investigation of its clinical and neurobiological effects in larger studies.

The main finding of this pilot study was a significant reduction in the TQ score (baseline vs. week 9) after thirty hours of this new manualized group therapy compared to the waiting list control group. Very recently, first results were presented from a randomized controlled study investigating mindfulness-based therapy in tinnitus patients. Notably, in this previous study neither mindfulness-based therapy nor relaxation training as a control condition exerted an immediate effect on tinnitus symptoms. This might at least in part be due to the large effect already yielded by the preceding psycho-education. However, during the follow-up period mindfulness-based treatment was superior to relaxation therapy.

Future studies should also address the specific relevance of the different therapeutic components and their potential neurobiological mechanisms. A significant increase in alpha power through meditation has been revealed by electroencephalographic  and magnetencephalographic studies. Alpha power in sensory areas is considered an indicator of inhibitory function  and an increase of alpha activity by neurobiofeedback or transcranial magnetic stimulation has been shown to result in reduced tinnitus perception. Thus it is tempting to speculate that the beneficial effects of mindfulness- and meditation- based therapy may be mediated by an increase in alpha power. Moreover, brain areas which are known to be involved in tinnitus such as the left hippocampus , the posterior cingulate cortex , the temporo-parietal junction, and the cerebellum  have recently been shown to be altered by mindfulness meditation.

We are well aware of the limiting factors of the pilot study conducted, such as the small sample size, the inherent problems of waiting-list control conditions , and the fact that treatment effects may depend on the instructor, which might limit generalization of the results. Nevertheless our pilot data indicate the promise of mindfulness- and body-psychotherapy-based therapy in the treatment of tinnitus and warrant further investigation of its clinical and neurobiological effects in larger studies.

Competing interests

Maria Holl has written the treatment manual for “Tinnitus Atemtherapie” and offers this treatment in private practice. MH has been supported by a grant from the Bundesverband der Innungskrankenkassen (IKK), Association of Health Insurances. The other authors declare no competing interests in relation to this article.

The electronic version of this article is the complete one and can be found online at:http://www.biomedcentral.com/1472-6882/12/235

In de neurowetenschappen is de laatste jaren veel onderzoek gedaan dat leidt naar een beter begrip van oorsuizingen. Men weet intussen dat Tinnitus in het brein ontstaat als reactie op een storing in het gehoor, zoals fantoompijn kan optreden na amputatie van een lichaamsdeel. Veel van de door Maria Holl ontwikkelde oefeningen sluiten aan op deze nieuwe inzichten. In Duitsland worden TAT-behandelingen door de ziektekostenverzekeringen vergoed. Dit is in Nederland helaas nog niet het geval.

In Duitsland wordt de Tinnitus Adem Therapie aanbevolen aan haar leden door de Deutsche Tinnitus-Liga. Dit is de zusterorganisatie van de NVVS in Nederland.

Door de ziektekostenverzekeraar GESOMED is er al eerder een onderzoek gedaan met positieve uitkomst:

Zusammenfassung der GESOMED Pilotstudie
zur Evaluation des Tinnitus-Atemtrainings nach Holl®
Ende 2005 veröffentlichte die Gesellschaft für sozialwissenschaftliche Forschung in der
Medizin mbH (GESOMED) eine Studie zur Qualität und Wirksamkeit des Tinnitus-Atemtrainings
nach Holl®. Ein von der IKK entwickeltes Evaluationssystem wurde für diesen
Zweck angepasst und zugrunde gelegt.
Die Teilnehmer zweier Kurse mit 35 Teilnehmern im Durchschnittsalter von 54,3 Jahren
wurden für die Studie zu drei verschiedenen Zeitpunkten befragt: zu Beginn und Ende der
Kurse und ein halbes Jahr später. Ziel war, die Struktur-, Prozess- und Ergebnisqualität des
Tinnitus-Atemtrainings zu bewerten. Abgefragt wurden u. a. die subjektiven Ziele der Kursteilnehmer
sowie Beschwerden, Krankheiten und Symptome, Vitalität und psychisches Wohlbefinden.
Mit der Note 1,8 (nach Schulnoten-System) wurden sowohl die Struktur- als auch die Prozessqualität
der Kurse bewertet. Überdurchschnittlich gut beurteilten die TeilnehmerInnen
die Verständlichkeit der Information, die Vermittlung der Inhalte und das Eingehen auf Fragen
und Bedürfnisse. Als häufigste subjektive Ziele gaben die KursteilnehmerInnen u. a.
folgende Punkte an: Rückgang der Tinnitus-Beschwerden, Umgang mit nervlicher Belastung
und die Fähigkeit, sich besser zu entspannen.
Direkt nach Abschluss des Kurses hatte die Mehrheit der KursteilnehmerInnen ihre genannten
subjektiven Ziele erreicht. Ein halbes Jahr später war ein noch größerer langfristiger
Erfolg zu verzeichnen: Über 50 Prozent gaben an, dass ihre Beschwerden zurückgegangen
sind. Knapp 80 Prozent erklärten, mit nervlichen Belastungen besser umgehen und sich
besser entspannen zu können.
Während 58 Prozent der TeilnehmerInnen vor dem Kurs wegen ihrer Ohrgeräusche in ärztlicher
Behandlung waren, halbierte sich die Zahl der Arztbesuche in der Zeit nach dem Kurs.
Von fünf Personen, die vor dem Kurs wegen psychischer Beschwerden in Behandlung
waren, nahmen im halben Jahr nach dem Kurs nur noch zwei Personen ärztliche Hilfe in
Anspruch.
Im Vergleich zu den Durchschnittswerten einer alters- und geschlechtsgleichen Stichprobe
aus dem Bundesgesundheitssurvey von 1998 zeigte sich, dass die Kursteilnehmer vor dem
Kurs deutlich schlechtere Werte im Vergleich zur Normstichprobe hatten. Vor allem die
Dimensionen Vitalität und psychisches Wohlbefinden verbesserten sich durch die Kursteilnahme
erheblich. 67 Prozent gaben in der langfristigen Perspektive eine Steigerung des
psychischen Wohlbefindens an.
Zusammenfassend lässt sich sagen, dass das Tinnitus-Atemtraining nach Holl® insbesondere
im Hinblick auf die Verbesserung der gesundheitlichen Lebensqualität und die subjektive
Befindlichkeit der TeilnehmerInnen wirksam ist. Hier wurde eine deutliche Annäherung
an die Normwerte der Normalbevölkerung erreicht. 90 Prozent der KursteilnehmerInnen
bewerteten den Kurs nach einem halben Jahr als Erfolg.
6.02.2006 Dr. Annette Vielhauer

foto handen met koraal 2