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An essential function of both the Association for Applied Psychophysiology and Biofeedback (AAPB) and the Society for Neuronal Regulation (SNR) is the systematic evaluation of psychophysiological interventions that have been developed for the treatment of medical and psychiatric disorders. In order to address scientific concerns regarding the efficacy of specific clinical applications of biofeedback, these two societies formed and Efficacy Task Force. The process to be used in the assessment of treatment efficacy, specificity and clinical utility is presented in the form of a template that will serve as the foundation for a series of scientific reviews and practice guidlines to be published by both societies.
The charge to the Efficacy Template Task Force requires the development of a template that will assist the Efficacy and Practice Guideline Panels in their review of the literature related to the clinical efficacy of psychophysiological interventions. The Panels will be required to use accepted scientific and clinical standards for determining whether a beneficial effect of treatment can be demonstrated. This document is intended as the template that will serve as a guideline for the Panels’ task. The ultimate goal is that of developing meaningful efficacy databases and practice guidelines for such interventions.
This task force was created as a collaborative effort by two professional societies (Association for Applied Psychophysiology and Biofeedback or AAPB; Society for Neuronal Regulation or SNR) to assist in providing a systematic framework for comprehensiveness and consistency in that endeavor. The guidelines that eventuate will, to the best extent possible, recognize the interdisciplinary nature of clinical interventions and, to the best extent possible, be developed by interdisciplinary panels and will be applicable to practitioners from all disciplines. The practice guidelines that are developed from this template are solely for the benefit of the individuals who seek intervention and assistance, whether they are referred to as patients, clients, or “consumers.” The efficacy statements and practice guidelines that result from this template will be regarded as informational and educational rather than as criteria for criticism.
Treatment guidelines that eventuate from this important process will greatly influence the health and well being of consumers of the services. Determinations of efficacy will be undertaken with that heavy responsibility foremost in mind. Therefore, the panel procedures will be open to public examination and members of the panels will be free of actual or apparent conflict of professional or financial interest.
Clinical psychophysiology uses variables that are quantifiable. The diagnostic criteria, independent variables, dependent variables, and measurable intervening variables will be included in the Panel deliberations. In methodological terms, the independent variables are specific and subject to experimental manipulation (e.g., sensor placement, bandwidths and frequencies, reinforcement contingencies). The dependent variables (e.g., physiological event being measured, response to treatment) can also be clearly specified. Often, intervening variables (e.g., change in brainwave features, improved motor unit recruitment) can be quantified.
While the primary function of the Panels is to examine evidence for efficacy, the Panels will also examine whether treatment specificity has been demonstrated.
Panels will recognize the distinction between “efficacy” and “clinical utility” and incorporate these distinctions into their deliberations and writings.
Treatment efficacy is determined from reports of clinical trials and/or case studies. The scientific and clinical credibility regarding treatment efficacy derives from a combination of clinical experience and clinical trials. Interventions often begin as anecdotal reports or case studies and ultimately are subject to formal and increasingly rigorous clinical trials, finally to be accepted as either “empirically supported” or rejected as useless. The particular design and structure of the clinical trials and the number of independent replications are important considerations for determining the degree to which a particular intervention can be claimed to be empirically supported or empirically validated. There is a generally accepted hierarchy of “scientific power” for each clinical trial design.
The panels will examine the research reports in light of published ethical standards governing human subject research. Two well-known documents are the Declaration of Helsinki, published by the World Medical Association (2000), and the Belmont Report (1979), published by the Department of Health and Human Services. Ethically critical issues such as informed consent, protections for vulnerable populations (e.g., children, developmentally disabled, cognitively impaired, severe psychopathology), and appropriate use of placebo or sham controls will be examined. The final reports will discuss, in a general sense, any ethical lapses or problems identified. Studies may be scientifically sound but ethically unacceptable.
2This is similar to the “Dodo Bird Verdict” resulting from studies of the efficacy of different bona fide psychotherapies. It is suggested by some that available evidence supports the idea that all psychotherapies are nearly equal in terms of efficacy, see Wampold, D. E., Mondin, G.W., Moody, M., and Ahn, H. (1997). The flat earth as a metaphor for the evidence of uniform efficacy of bona fide psychotherapies: Reply to Crits-Christoph (1997) and Howard et al. (1997). Psychological Bulletin, 122 (3): 226–230.
3While the use of randomized, controlled group designs enables a clinical researcher to control for certain sources of experimental “error,” it is erroneous to conclude that well-designed, case-controlled studies are of limited value. See Benson and Hartz (2000) for a comprehensive review of this topic.