title: Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework.
abstract: In psychiatry, comparative analyses of therapeutic options and the aggregation of data from clinical trials across different therapeutic approaches play an important role in clinical decision making, treatment guidelines, and health policy. This approach assumes that trials of pharmacological and behavioural therapies generally produce the same level of evidence when properly designed. However, trial design for behavioural interventions has some unique characteristics and control groups vary widely, which influence the effects observed in any given trial. In this Personal View, we review various control conditions typically used in psychiatry, outline their effect on the internal validity and expected effect size of a trial, and propose a decision framework for choosing a control condition depending on the risk to the patient population and the stage of development of the therapeutic intervention. We argue that the choice of control group and its justification need to be taken into consideration when comparing behavioural and pharmacological therapies.
authors.affiliation: Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Institut für Neuroimmunologie und Multiple Sklerose (INIMS), Zentrum für Molekulare Neurobiologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. Electronic address: stefan.gold@charite.de.
authors.forename: Stefan M
authors.initials: SM
authors.lastname: Gold
authors.affiliation: Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Tübingen, Tübingen, Germany.
authors.forename: Paul
authors.initials: P
authors.lastname: Enck
authors.affiliation: Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Hasselmann
authors.affiliation: Institut für Medizinische Statistik, Universitätsmedizin Göttingen, Göttingen, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Leipzig, Stiftung Deutsche Depressionshilfe, Leipzig, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Hegerl
authors.affiliation: Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Mohr
authors.affiliation: Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Otte
mesh_terms: D001521:Behavior Therapy; D035061:Control Groups; D003657:Decision Making; D006801:Humans; D011570:Psychiatry / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design