The control group dilemma in clinical research: applications for psychosocial and behavioral medicine trials.
OBJECTIVE
Clinical research on psychosocial and behavioral medicine interventions has burgeoned in the past two decades, so much so that sole reliance on standard no-treatment control conditions may no longer be appropriate or feasible. We discuss the ethical, theoretical, scientific, and statistical considerations that shape current clinical outcomes research for psychosocial and behavioral medicine interventions.


RESULTS
Secondary analysis of a psychosocial randomized trial (N = 127) illustrates some of these points.


CONCLUSIONS
A new design for randomized clinical trials is described that does not require a no-treatment control group, and that reveals dose-response relationships between interventions and treatment outcomes.
Schwartz
C E
CE
Behavorial Science Research Program, Frontier Science & Technology Research Foundation, Inc., Brookline, Massachusetts 02167-2104, USA. schwartz@jimmy.harvard.edu
Chesney
M A
MA
Irvine
M J
MJ
Keefe
F J
FJ
D001521:Behavior Therapy / Q000706:statistics & numerical data*; D015982:Bias; D018592:Cross-Over Studies; D006801:Humans; D015990:Placebo Effect; D011613:Psychotherapy / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome