Clinical trial NCT04682197: Cereset Research In Healthcare Workers During COVID-19
Official title: Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Personnel
Stress
Anxiety
Insomnia
Hyperarousal
Corona Virus Infection
Covid19
Keywords: Anxiety
Stress
Insomnia
Cereset Research
Hyperarousal
Brain electrical activity
Autonomic Dysregulation
Neurotechnology
HIRREM
COVID-19
Coronavirus
Allostasis
neuromodulation
acoustic stimulation
COVID
healthcare worker
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Susanne Marcus Collins Foundation, Inc.
First posted: 2020-12-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling healthcare workers aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 4 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

Detailed description: The primary objective of this study is to evaluate the effect of CR to improve the Perceived Stress Scale (PSS) in healthcare workers with symptoms of stress, compared to waitlist control, at 4-6 weeks post intervention.

Secondary objectives include evaluating the effect of CR on the self-reported measures of sleep and anxiety. Exploratory measure include a variety of symptom inventories (mood, post-traumatic stress, quality of life, social support, and cognitive function), and 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 166 participants will be enrolled in order to have at least 138 to complete the study. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 4 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 Perceived Stress Scale (PSS) which assesses the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Secondary outcomes include insomnia (Insomnia Severity Index, ISI) and anxiety (Generalized Anxiety Disorder-7, GAD-7). Exploratory outcomes to be collected include symptom inventories for depression (Center for Epidemiological Studies- Depression Scale, CES-D), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function, Fatigue Severity Scale (FSS) for fatigue, and mental health (Depression, Anxiety, and Stress Scale, DASS -21). Details about COVID-19 status, interaction, workplace engagement, healthcare utilization, and exposure will be collected. 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. Sessions will be administered over 10 days. 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 4 CR sessions and will continue to be followed for data collections at 0-7 days (V4) after completing their sessions, and 4-6 weeks (V5) after V4. Because V4 and V5 are not required, these visits will be exploratory. 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 exploratory 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.

Eligibility criteria: Inclusion Criteria:

* Employed Healthcare workers aged 18 years and older.
* Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
* Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).

Exclusion Criteria:

* Unable, unwilling, or incompetent to provide informed consent/assent.
* Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
* Severe hearing impairment (because the subject will be using ear buds during CR).
* Weight is over the chair limit (400 pounds).
* Currently enrolled in another active intervention research study.
* Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
* Prior use of: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, Eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
* Known seizure disorder.
* Thoughts of suicide within the last 3 months.
* Current, significant symptoms of long-COVID.
* Current medical student.

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Secondary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Other outcomes:
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Posttraumatic Stress Disorder (PTSD) Checklist for Civilians (PCL-C)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Fatigue Severity Scale (FSS)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Quality of Life Scale (QOLS)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Interpersonal Support Evaluation List (ISEL-12)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Multiple Ability Self-Report Questionnaire (MASQ)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in The Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Heart Rate Variability (HRV)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
measure: Change in Heart Rate (HR)
timeFrame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
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