A clinical demonstration model for assessing the effectiveness of therapeutic interventions: an expanded clinical trials methodology.

Both the evaluation of current treatment interventions and the innovation of new ones are vital to maintaining a viable clinical profession. In the field of psychology, however, often there are serious challenges facing these worthy endeavors. This article reviews several problems and limitations with evaluation of innovative psychotherapy treatments in clinical practice and suggests a strategy to overcome these. This approach, which we term the "Systematic Clinical Demonstration Methodology," (SCDM) combines the skills of clinicians with the rigors of clinical trials methods and permits concurrent clinical innovation and scientific evaluation. Here we suggest that the SCDM approach allows innovative practitioners to assist in the development and evaluation of promising clinical interventions by working closely with clinical trials researchers. This allows innovative clinicians to demonstrate new treatment approaches, while clinical researchers evaluate the effectiveness and safety of these interventions using clinical trials methods that incorporate qualitative data. We suggest that this approach can result in the development and evaluation of new treatment innovations more quickly and cost effectively than traditionally has been the case. In addition, some limitations commonly associated with clinical trials, such as not treating patients typically found in clinical practice, failing to treat patients with multiple disorders, or treating patients from different cultural or sociodemographic groups, can be more effectively addressed. Our experiences with using this method to evaluate different psychotherapy treatments for posttraumatic stress disorder are presented as an example of this new approach.