Biofeedback Efficacy

We encourage you to purchase Evidence-Based Practice in Biofeedback and Neurofeedback (4th ed.) from the AAPB Bookstore. Educators and practitioners consider it an indispensable reference.
"Evidence-based practice is a process of using the best evidence, preferably research findings, to guide the delivery of health services. Levels of evidence range from case reports and observational studies to randomized clinical trials.
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Evidence-Based Practice in Biofeedback and Neurofeedback (4th ed.) updates and expands the 3rd edition, and provides helpful tables for quick reference. It fills a void in the biofeedback and neurofeedback practice world: the need for a standardized assessment of clinical efficacy and effectiveness for feedback-based therapies.
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Evidence-based practice must consider both efficacy in controlled research settings and effectiveness in the real world of clinical practice. Neither the general public nor the novice biofeedback practitioner can always assess which applications are well documented and which remain more experimental. Attending biofeedback and neurofeedback conferences, one hears discussion of many promising new approaches, and websites often claim 'well-documented efficacy' for various new approaches. Nevertheless, today’s research climate has higher standards for efficacy and effectiveness than were current during much of the time in which biofeedback and neurofeedback evolved. This publication applies systematic standards of research methodology to biofeedback and neurofeedback practice."
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Efficacy
Khazan, Shaffer, Moss, Lyle, and Rosenthal's (2023) ratings are listed for the five levels of efficacy recommended by a joint Task Force and adopted by the Boards of Directors of the Association for Applied Psychophysiology (AAPB) and the International Society for Neuronal Regulation (ISNR).[172] From weakest to strongest, these levels include: not empirically supported, possibly efficacious, probably efficacious, efficacious, and efficacious and specific.
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Level 1: Not empirically supported. This designation includes applications supported by anecdotal reports and/or case studies in non-peer-reviewed venues. Khazan and colleagues (2023) assigned neurofeedback connectivity protocols for seizures to this category.[172]
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Level 2: Possibly efficacious. This designation requires at least one study of sufficient statistical power with well-identified outcome measures but lacking randomized assignment to a control condition internal to the study. Khazan and colleagues assigned asthma, functional abdominal pain syndrome, hyperhidrosis, and vasovagal syndrome to this category.[172]
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Level 3: Probably efficacious. This designation requires multiple observational studies, clinical studies, waitlist-controlled studies, and within subject and intrasubject replication studies that demonstrate efficacy. Khazan and colleagues assigned chronic obstructive pulmonary disease, concussion, epilepsy non-seizure symptoms, fibromyalgia, immune function, motion sickness, and worksite-related pain to this category.[172]
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Level 4: Efficacious. This designation requires the satisfaction of six criteria:
(a) In a comparison with a no-treatment control group, alternative treatment group, or sham (placebo) control using randomized assignment, the investigational treatment is shown to be statistically significantly superior to the control condition or the investigational treatment is equivalent to a treatment of established efficacy in a study with sufficient power to detect moderate differences.
(b) The studies have been conducted with a population treated for a specific problem, for whom inclusion criteria are delineated in a reliable, operationally defined manner.
(c) The study used valid and clearly specified outcome measures related to the problem being treated.
(d) The data are subjected to appropriate data analysis.
(e) The diagnostic and treatment variables and procedures are clearly defined in a manner that permits replication of the study by independent researchers.
(f) The superiority or equivalence of the investigational treatment has been shown in at least two independent research settings.
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Khazan and colleagues assigned adult headache, cerebral palsy, epilepsy seizures, essential hypertension, fecal incontinence, Generalized Anxiety Disorders, irritable bowel syndrome, low back pain, Post-Traumatic Stress Disorder Raynaud's, stroke, and [[temporomandibular disorders] to this category.[172]
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Level 5: Efficacious and specific. The investigational treatment must be shown to be statistically superior to credible sham therapy, pill, or alternative bona fide treatment in at least two independent research settings. Khazan and colleagues (2023) assigned asthma, Attention Deficit Hyperactivity Disorder, depression, diabetes glycemic control, erectile dysfunction, panic disorder, and pre-eclampsia, to this category.[172]

