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. 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.
Duke Scholars
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Related Subject Headings
- Treatment Outcome
- Research Design
- Reproducibility of Results
- Randomized Controlled Trials as Topic
- Psychotherapy
- Psychiatry
- Placebo Effect
- Humans
- Cross-Over Studies
- Bias
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Treatment Outcome
- Research Design
- Reproducibility of Results
- Randomized Controlled Trials as Topic
- Psychotherapy
- Psychiatry
- Placebo Effect
- Humans
- Cross-Over Studies
- Bias