Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up

被引：64

作者：

Arnold, L. Eugene ^{[1
]}

Arns, Martijn ^{[1
]}

Barterian, Justin ^{[1
]}

Bergman, Rachel ^{[1
]}

Black, Sarah ^{[1
]}

deBeus, Roger ^{[1
]}

Higgins, Teryll ^{[1
]}

Hollway, Jill A. ^{[1
]}

Kerson, Cynthia ^{[1
]}

Lightstone, Howard ^{[1
]}

McBurnett, Keith ^{[1
]}

Monastra, Vincent ^{[1
]}

Buchan-Page, Kristin ^{[1
]}

Pan, Xueliang ^{[1
]}

Rice, Robert ^{[1
]}

Roley-Roberts, Michelle E. ^{[1
]}

Schrader, Constance ^{[1
]}

Tan, Yubo ^{[1
]}

Williams, Craig E. ^{[1
]}

机构：

[1] Ohio State Univ, Psychiat & Behav Hlth, 395E McCampbell Hall,1581 Dodd Dr, Columbus, OH 43210 USA

来源：

JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY | 2021年 / 60卷 / 07期

关键词：

ADHD; neurofeedback; clinical trials; double-blind; attention-deficit; DEFICIT-HYPERACTIVITY DISORDER; PHYSICAL-ACTIVITY; EEG NEUROFEEDBACK; ADHD; CHILDREN; BIOFEEDBACK; RELAXATION; SYMPTOMS; THERAPY; MTA;

D O I：

10.1016/j.jaac.2020.07.906

中图分类号：

B844 [发展心理学（人类心理学）];

学科分类号：

040202 ;

摘要：

Objective: To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback [NF]) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit. Method: In a 2-site double-blind randomized clinical trial, 144 children aged 7 to 10 years with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR) >= 4.5 were randomized 3:2 to deliberate TBR downtraining versus a control of equal duration, intensity, and appearance. Two early dropouts left 142 children for modified intent-to-treat analysis. The control used prerecorded electroencephalograms with the participant's artifacts superimposed. Treatment was programmed via Internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists and 93.2% by NF expert monitor. The primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because the expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated. Results: Blinding was excellent. Although both groups showed significant improvement (p < .001, d = 1.5) in parent/teacher-rated inattention from baseline to treatment end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d = 0.01, p = .965 at treatment end; d = 0.23, p = .412 at 13-month follow-up). Responders (Clinical Global Impression-Improvement [CGI-I] = 1-2) were 61% of NF and 54% of controls (p = .36). Adverse events were distributed proportionally between treatments. The 13-month follow-up found nonsignificant improvement from treatment end for NF (d = 0.1), with mild deterioration for controls (d = -0.07). NF required significantly less medication at follow-up (p = .012). Conclusion: This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.

引用

页码：841 / 855

页数：15

共 37 条

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