Status:
COMPLETED
Cereset Research In Healthcare Workers During COVID-19
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
The Susanne Marcus Collins Foundation, Inc.
Conditions:
Health Personnel
Stress
Eligibility:
All Genders
18+ years
Phase:
NA
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 peri...
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 week...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04682197
Start Date
December 14 2021
End Date
October 10 2023
Last Update
September 19 2024
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104