Modest Effects of Neurofeedback-Assisted Meditation Using a Wearable Device on Stress Reduction: A Randomized, Double-Blind, and Controlled Study

Abstract

Background To evaluate the therapeutic effectiveness and safety of a neurofeedback wearable device for stress reduction. Methods A randomized, double-blind, controlled study was designed. Participants had psychological stress with depression or sleep disturbances. They practiced either neurofeedback-assisted meditation (n = 20; female, 15 [75.0%]; age, 49.40 ± 11.76 years) or neurofeedback non-assisted meditation (n = 18; female, 11 [61.1%]; age, 48.67 ± 12.90 years) for 12 minutes twice a day for two weeks. Outcome variables were self-reported questionnaires, including the Korean version of the Perceived Stress Scale, Beck Depression Inventory-II, Insomnia Severity Index, Pittsburgh Sleep Quality Index, and State Trait Anxiety Index, quantitative electroencephalography (qEEG), and blood tests. Satisfaction with device use was measured at the final visit. Results The experimental group had a significant change in PSS score after two weeks of intervention compared with the control group (6.45 ± 0.95 vs. 3.00 ± 5.54, P = 0.037). State anxiety tended to have a greater effect in the experimental group than in the control group ( P = 0.078). Depressive mood and sleep also improved in each group, with no significant difference between the two groups. There were no significant differences in stress-related physiological parameters, such as stress hormones or qEEG, between the two groups. Subjective device satisfaction was significantly higher in the experimental group than in the control group ( P = 0.008). Conclusion Neurofeedback-assisted meditation using a wearable device can help improve subjective stress reduction compared with non-assisted meditation. These results support neurofeedback as an effective adjunct to meditation for relieving stress. Trial Registration Clinical Research Information Service Identifier: KCT0007413