Wie adhärent wird Clinical Management in randomisierten, kontrollierten Studien durchgeführt?

 

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Zusammenfassung

Clinical Management (CM) stellt in der Depressionsforschung eine häufig verwendete Kontrollbedingung dar. In dieser Arbeit wurde erstmals die Adhärenz von standardisiertem CM und dessen Einfluss auf das Behandlungsergebnis bei Depressiven untersucht. 43 Patienten mit einer Major Depression erhielten im Rahmen einer randomisierten, kontrollierten Studie fünf Wochen lang neben einer medikamentösen Standardtherapie dreimal wöchentlich CM-Sitzungen. Insgesamt wurden 167 zufällig ausgewählte, über den gesamten Behandlungsverlauf verteilte Audioaufnahmen dieser Sitzungen mithilfe einer Adhärenzskala ausgewertet. Der Behandlungserfolg wurde anhand der Hamilton-Depressionsskala eingeschätzt. Die Psychiater führten insgesamt hochqualitatives CM mit stark supportiven Anteilen durch. Die vorgegebene maximale Sitzungslänge wurde dabei überschritten. Reines CM war mit einer höheren Responserate assoziiert. Die Zusatzdiagnose einer Persönlichkeitsstörung sowie die klinische Erfahrung des Behandlers in Jahren waren Prädiktoren für weniger adhärente Behandlung, hatten jedoch keine Moderatorfunktion.

Abstract

CM is increasingly used as a control condition in depression research. In the present study, the adherence of standardized CM sessions and their influence on outcome in depressed inpatients was investigated for the first time. In a randomized controlled trial, 43 inpatients with a diagnosis of Major Depression received medication treatment plus three-weekly CM sessions for 5 weeks. The 17-item version of the Hamilton Depression Rating Scale was the outcome measure. A total of 167 randomly selected audiotapes of CM sessions were evaluated using an adherence scale. The CM sessions delivered by psychiatric residents showed overall a high quality and included extensive support by the physician. The length of sessions was extended. The purity of sessions was associated with higher response rates. A diagnosis of Axis II-disorders or -traits and the clinical experience of the physician in years were predictors for less adherend treatments. However, both of them did not function as moderator variables.

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Elisabeth Schramm

Universitätsklinik Freiburg, Abteilung für Psychiatrie und Psychotherapie

Hauptstraße 5

79104 Freiburg

Email: Elisabeth.Schramm@uniklinik-freiburg.de