Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework
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Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework. / Gold, Stefan M; Enck, Paul; Hasselmann, Helge; Friede, Tim; Hegerl, Ulrich; Mohr, David C; Otte, Christian.
In: LANCET PSYCHIAT, Vol. 4, No. 9, 09.2017, p. 725-732.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework
AU - Gold, Stefan M
AU - Enck, Paul
AU - Hasselmann, Helge
AU - Friede, Tim
AU - Hegerl, Ulrich
AU - Mohr, David C
AU - Otte, Christian
N1 - Copyright © 2017 Elsevier Ltd. All rights reserved.
PY - 2017/9
Y1 - 2017/9
N2 - 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.
AB - 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.
KW - Journal Article
KW - Review
U2 - 10.1016/S2215-0366(17)30153-0
DO - 10.1016/S2215-0366(17)30153-0
M3 - SCORING: Journal article
C2 - 28396067
VL - 4
SP - 725
EP - 732
JO - LANCET PSYCHIAT
JF - LANCET PSYCHIAT
SN - 2215-0374
IS - 9
ER -