Abstract

The primary purpose behind effectiveness research is to determine whether a treatment with demonstrated efficacy has utility when administered to the general population. The main questions these studies are meant to answer are these: Can the typical patient respond to treatment? Is the treatment acceptable to the typical patient? Can the treatment be administered safely and in its entirety in the typical treatment setting? Is the treatment under study significantly better than the community standard of care both from a cost and outcome perspective? Answering these questions is meant to provide sufficient information to providers and policymakers so that effective interventions can be adopted and become the new community standard. For this research to make a meaningful impact on a provider and policymaker's decision to change the status quo, study interventions should be compared to the existing community standard of treatment, often referred to as treatment as usual (TAU). From an ethical perspective, this decision may not always be the safest choice. In some populations, TAU may mean no treatment at all, and in others TAU may be worse than withholding treatment. The effectiveness researcher is then caught between the pull to do no harm and the need for research to have an impact on change. The purpose of this article is to highlight certain conditions when TAU is ethically acceptable and to discuss alternatives when TAU may be an unethical treatment condition. For purposes of precision, we focus exclusively on psychotherapy effectiveness research rather than system-intervention research or medication-intervention research