From the Department of Psychology, Ohio University, Athens, OH (Dr. Holroyd); Division of Psychology, Cincinnati Children's Hospital, Cincinnati, OH (Dr. Powers); and Institute for Human and Machine Cognition, University of West Florida, Pensacola, FL (Dr. Andrasik).
Methodological Issues in Clinical Trials of Drug and Behavior Therapies
Article first published online: 9 JUN 2005
Headache: The Journal of Head and Face Pain
Volume 45, Issue 5, pages 487–492, May 2005
How to Cite
Holroyd, K. A., Powers, S. W. and Andrasik, F. (2005), Methodological Issues in Clinical Trials of Drug and Behavior Therapies. Headache: The Journal of Head and Face Pain, 45: 487–492. doi: 10.1111/j.1526-4610.2005.05100.x
- Issue published online: 9 JUN 2005
- Article first published online: 9 JUN 2005
- Accepted for publication January 2, 2005.
- clinical trial;
- behavior therapy;
- drug therapy;
Trials that compare drug and behavior therapies or evaluate combination therapy raise special methodological issues. This article reviews these methodological issues and, where possible, offers guidelines for addressing them. Sources of bias in the selection and recruitment of participants and in the measurement of treatment outcomes are discussed. In addition, methodological problems presented by the differing structures of behavior and drug therapy, by confounding variables, such as allegiance effects, differential expectations and preferences for drug or behavior therapy, and differential adherence with drug or behavior therapy also are reviewed. Issues in the selection of appropriate control groups are also discussed.