1. Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up
- Author
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Constance Schrader, Roger deBeus, Laurence M. Hirshberg, Vincent J. Monastra, Robert A. Rice, Justin A. Barterian, Martijn Arns, Keith McBurnett, Sarah R. Black, Xueliang Pan, C. Keith Conners, Craig E. Williams, Rachel Rhodes, Kristin A. Buchan-Page, Cynthia Kerson, Nicholas Lofthouse, Joel F. Lubar, Rachel Bergman, Yubo (Jeremy) Tan, Teryll Higgins, Sudeshna Dasgupta, Michelle E. Roley-Roberts, Jill A. Hollway, Shea Connor, Howard Lightstone, L. Eugene Arnold, and Adult Psychiatry
- Subjects
medicine.medical_specialty ,Blinding ,SYMPTOMS ,medicine.medical_treatment ,CHILDREN ,RELAXATION ,Placebo ,Biofeedback ,THERAPY ,Article ,law.invention ,Double blind ,Randomized controlled trial ,Double-Blind Method ,law ,DEFICIT-HYPERACTIVITY DISORDER ,Developmental and Educational Psychology ,adhd ,Medicine ,Attention deficit hyperactivity disorder ,Humans ,0501 psychology and cognitive sciences ,Child ,clinical trials ,business.industry ,attention-deficit ,05 social sciences ,EEG NEUROFEEDBACK ,Electroencephalography ,neurofeedback ,Placebo Effect ,medicine.disease ,Clinical trial ,Psychiatry and Mental health ,Treatment Outcome ,PHYSICAL-ACTIVITY ,BIOFEEDBACK ,Attention Deficit Disorder with Hyperactivity ,MTA ,Physical therapy ,Neurofeedback ,double-blind ,business ,050104 developmental & child psychology ,Follow-Up Studies - Abstract
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
- Published
- 2021