Cereset Research Reduces Symptoms of Stress, Insomnia, and Anxiety in Healthcare Workers: a Randomized Clinical Trial
Charles Tegeler1, Catherine Tegeler1, Gregory Russell2, Dawn Kellar1, Kenzie Brown1, Suzanne Danhauer3, Hossam Shaltout4, Heidi Munger Clary1
1Neurology, 2Public Health Sciences - Biostatistics and Data Science, 3Public Health Sciences - Social Sciences, 4Hypertension & Vascular Research Center, Wake Forest University School of Medicine
Objective:
To test Cereset Research™ (CR), for reducing stress in healthcare workers (HCW).
Background:
CR is a closed-loop, acoustic stimulation neurotechnology which in prior studies improved stress in other populations. We evaluate CR for stressed HCW.
Design/Methods:
Adult HCW reporting elevated perceived stress levels (Perceived Stress Scale, PSS, ≥14) enrolled in this waitlist controlled randomized trial. Following consent and baseline measures (V1), participants were randomized to early intervention (EI) with 4, 36-minute sessions of CR (tones linked to brainwaves) or waitlist control condition (WC). Primary outcome assessment occurred 4-7 weeks (V3) later. The study was powered to detect a moderate clinically significant between-group difference in PSS score change at V3 (primary outcome). Secondary outcomes were Insomnia Severity Index (ISI) and Generalized Anxiety Disorder-7 (GAD-7). Control participants could opt to receive CR intervention following V3 assessment. Repeated measures ANOVA analyzed the longitudinal changes between groups.
Results:
Of 144 HCW enrolled, 86% were female, 40% nurses, mean age 44.7 (SD 11.6). Demographic and clinical characteristics were similar between groups. Ten dropped out, 5 per group. Mean PSS scores in EI were 21.4 (SD 4.8) at V1, 13.3 (SE 0.6) at V3, and in WC were 20.9 (SD 4.5) at V1, 19.9 (SE 0.6) at V3. The adjusted between-group PSS differences at V3 were EI -7.8 (SE 0.6), WC -1.2 (SE 0.6) (p<0.0001). Adjusted between-group differences were also significant for secondary outcome scores; ISI: EI -6.3 (SE 0.6), WC -0.5 (SE 0.6) (p<0.0001); GAD-7: EI -5.6 (SE 0.5), WC -1.3 (SE 0.5) (p<0001). The intervention was well tolerated.
Conclusions:
This randomized, waitlist-controlled trial of noninvasive acoustic neuromodulation showed clinically meaningful, statistically significant improvement in perceived stress, anxiety and insomnia among stressed HCW. This intervention may be promising for implementation in health systems to reduce HCW stress.