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

Importance Brain-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. Objective To evaluate the feasibility and preliminary efficacy of a novel, personalized, BCI-based intervention integrating mindfulness principles for anxiety regulation in the home setting. Design An open-label, two-arm randomized clinical trial was conducted from January 2021 to December 2021. Setting The study was conducted at Duke-NUS Medical School, Singapore. Participants Thirty 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. Intervention The intervention was self-administered by the participants and involved eight 30-minute sessions held at home over 2 weeks. Main Outcomes and Measures The 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. Results The 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 Relevance These 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 Registration [ClinicalTrials.gov][1] [NCT04626713][2]; ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04626713 ### Funding Statement The authors received no external funding for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Institutional Review Board of the National University of Singapore gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * BAI-II : Beck Anxiety Inventory II CBT : cognitive behavior therapy DASS-21 : Depression Anxiety Stress Scale 21-items DERS-SF : Difficulties in Emotion Regulation Scale short-form EEG : electroencephalography INTG : intervention group ISI : Insomnia Severity Index MAAS : Mindfulness Awareness Attention Scale SSRIs : selective serotonin reuptake inhibitors STAI : State-trait Anxiety Inventory WCG : waitlist control group [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04626713&atom=%2Fmedrxiv%2Fearly%2F2024%2F03%2F02%2F2024.03.01.24303187.atom