Cereset Research In Healthcare Workers During COVID-19

Summary

Participation Requirements

Description

The primary objective of this open label exploratory study is to evaluate the effect of CR to improve the Impact of Event Scale-Revised (IES-R) in healthcare workers at Wake Forest Baptist Health with symptoms of stress and anxiety. The secondary objective is to evaluate the effect of CR on a variet...

The primary objective of this open label exploratory study is to evaluate the effect of CR to improve the Impact of Event Scale-Revised (IES-R) in healthcare workers at Wake Forest Baptist Health with symptoms of stress and anxiety. The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories (sleep, perceived stress, mood, anxiety, post-traumatic stress, quality of life, social support, and cognitive function). Exploratory Objective: Assess the impact of CR on autonomic cardiovascular regulation (heart rate variability, HRV). Methods: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling adults aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 120 participants will be enrolled in order to have at least 100 to complete the study. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 2 CR sessions of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only, and will serve as a control group. Participants in both groups will continue their other current care throughout the study. The primary outcome will be interval change in the Impact of Event Scale-Revised (IES-R) which assesses reactions to stressful life events like COVID-19 by looking at avoidance, intrusion, and hyperarousal. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI), depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), stress (Perceived Stress Scale, PSS), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), and the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function. Pre- and post-intervention data collection of physiological parameters (Heart rate, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability) will be assessed as exploratory outcomes. All measures will be collected at an enrollment visit (V1), and participants will be randomly assigned to the EI or DI groups. For those in the EI group, the intervention will begin 0-7 days thereafter. Post-intervention data collections will be obtained at 0-7 days (V2) after completion of the intervention, and 4-6 weeks (V3, primary outcome) after the V2. Following V3, those in the DI group will be offered the opportunity to cross over to receive two sessions of Cereset Research, and will continue to be followed for data collections at 0-7 days (V4) after completing their crossover sessions, and 4-6 weeks (V5) after V4. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for secondary outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.

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