The control group dilemma in clinical research: applications for psychosocial and behavioral medicine trials.


Journal Article

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. METHOD AND 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.

Full Text

Duke Authors

Cited Authors

  • Schwartz, CE; Chesney, MA; Irvine, MJ; Keefe, FJ

Published Date

  • July 1997

Published In

Volume / Issue

  • 59 / 4

Start / End Page

  • 362 - 371

PubMed ID

  • 9251155

Pubmed Central ID

  • 9251155

International Standard Serial Number (ISSN)

  • 0033-3174

Digital Object Identifier (DOI)

  • 10.1097/00006842-199707000-00005


  • eng

Conference Location

  • United States