Personalized Brain-Computer Interface-based Intervention for Mindful Anxiety Regulation in Young Adults: A Randomized Clinical Trial

ImportanceBrain-computer interface-(BCI-) based interventions are promising means for self-administered anxiety treatment due to their non-invasiveness and portability. However, few studies have explored their viability in the home setting. ObjectiveTo evaluate the feasibility and preliminary efficacy of a novel, personalized, BCI-based intervention integrating mindfulness principles for anxiety regulation in the home setting. DesignAn open-label, two-arm randomized clinical trial was conducted from January 2021 to December 2021. SettingThe study was conducted at Duke-NUS Medical School, Singapore. ParticipantsThirty young adults from the community aged 21-35 with at least moderate anxiety were randomized 1:1 to either the intervention or waitlist-control group. InterventionThe intervention was self-administered by the participants and involved eight 30-minute sessions held at home over 2 weeks. Main Outcomes and MeasuresThe primary outcomes were safety, acceptability, and anxiety (Beck Anxiety Inventory II, State-Trait Anxiety Inventory [Form Y], and electroencephalography [EEG] data). Secondary outcomes were quality of sleep (Insomnia Severity Index), emotion regulation (Difficulties in Emotion Regulation Scale), mindful awareness (Mindfulness Awareness Attention Scale), and depression and stress subscales in the Depression Anxiety Stress Scale-21. ResultsThe intervention was safe and acceptable. No severe adverse events were reported. The attrition rate was 40%, predominantly due to technical issues. Pooled analyses indicated a significant reduction in anxiety, depression, stress, and insomnia from pre- to post-intervention. Improvements in anxiety were supported by physiological changes. Participants also reported significantly greater mindful awareness, access to emotion regulation strategies, and control over impulses. Conclusion and RelevanceThese findings suggest that our BCI-based intervention is feasible and potentially efficacious for participants to entrain anxiety regulation independently at home. A larger trial is warranted. Trial RegistrationClinicalTrials.gov NCT04626713; https://tinyurl.com/27hn2m76