Background: 43 % of people who are diagnosed with COVID-19 will experience persistent symptoms, also known as "long COVID," which lasts past the recovery of the acute infection. Long COVID symptoms overlap with symptoms that the Biosound Therapy System (BTS) has been shown to improve. The BTS is a multimodal treatment that includes biofeedback, vibroacoustic therapy synchronized with music that plays binaural beats, and video content. This study aimed to determine feasibility for a future full-scale Randomized Controlled Trial (RCT) and explore the impact of the BTS on long COVID symptoms.
Methods: This pre-post pilot study was conducted in an outpatient mental health clinic. Adults aged 20-65 years old with persistent COVID-19 symptoms were screened and randomly assigned to the intervention or control group. The intervention group was given 8 Biosound Therapy sessions during a period of 4 weeks. All participants were assessed at baseline and at post-intervention using the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), Cambridge Brain Sciences (CBS) tasks, and the COVID-19 Persistent Symptom Questionnaire. The feasibility outcomes were recruitment rates, retention rates, and open-ended questions about participants' experiences.
Results: 15 participants enrolled in the study and 13 completed the study (9 intervention, 4 control). Trial recruitment ended prematurely due to the emergence of the Omicron variant of COVID-19. Participants responded to open-ended questions with only positive remarks and made no comments on the study not being feasible. A Wilcoxon signed-rank test indicated that compared to baseline, participants in the intervention group had significant improvement in their GAD-7 score, PHQ9 score, 2 Cambridge Brain Science tasks ("Odd" and "Double Trouble"), fatigue, and difficulties in concentrating or remembering (p < 0.05; 95 % CI).
Conclusion: The intervention group showed promising improvement without reported side effects. A full-scale RCT is feasible as long as the recruitment setting is changed to a location that allows access to more patients with long COVID. Results were limited due to the small sample size; therefore, a full-scale trial is needed.
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