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Behavioural Intervention

Cereset for Stress Related to COVID-19

N/A

Waitlist Available

Led By Charles H Tegeler, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Employed Healthcare workers aged 18 years and older

Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, v2 (0-7 days after final session), and v3 (4-6 weeks after v2)

Awards & highlights

Study Summary

This trial will study whether using Cereset Research can help improve stress symptoms in healthcare workers during the COVID-19 pandemic.

Who is the study for?

This trial is for healthcare workers over 18 who are feeling stressed, as shown by scoring at least 14 on the Perceived Stress Index. They must be able to follow instructions and sit still for an hour. It's not for those over 400 pounds, with severe hearing loss, a history of certain brain treatments or therapies within the last month, seizure disorders, recent suicidal thoughts, long-COVID symptoms, medical students or anyone in another study.Check my eligibility

What is being tested?

The trial tests Cereset Research to see if it can help healthcare workers manage stress during COVID-19. Participants will receive this intervention in sessions where they need to sit still and listen through earbuds. The study includes a waitlist control group for comparison.See study design

What are the potential side effects?

Since Cereset Research involves non-invasive brainwave optimization using sound through earbuds, side effects might include discomfort from sitting still or wearing earbuds but no significant medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an employed healthcare worker and I am 18 years old or older.

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I feel stressed and my stress score is 14 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, v2 (0-7 days after final session), and v3 (4-6 weeks after v2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, v2 (0-7 days after final session), and v3 (4-6 weeks after v2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, v2 (0-7 days after final session), and v3 (4-6 weeks after v2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Perceived Stress Scale (PSS)

Secondary outcome measures

Change in Generalized Anxiety Disorder-7 (GAD-7)

Change in Insomnia Severity Index (ISI)

Other outcome measures

Change in Center for Epidemiologic Studies Depression Scale (CES-D)

Change in Fatigue Severity Scale (FSS)

Change in Heart Rate (HR)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continued Current CareExperimental Treatment1 Intervention

Participants will continue their current care.

Group II: Cereset ResearchActive Control1 Intervention

For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,123 Total Patients Enrolled

The Susanne Marcus Collins Foundation, IncUNKNOWN

1 Previous Clinical Trials

150 Total Patients Enrolled

Charles H Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences

6 Previous Clinical Trials

474 Total Patients Enrolled

Media Library

Cereset Research (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04682197 — N/A

Health Care Worker Research Study Groups: Cereset Research, Continued Current Care

Health Care Worker Clinical Trial 2023: Cereset Research Highlights & Side Effects. Trial Name: NCT04682197 — N/A

Cereset Research (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682197 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate participation count of this research study?

"Yes, the clinicaltrials.gov database confirms that this medical trial is actively enrolling patients. It was first posted on December 14th 2021 and last updated November 28th 2022. The study aims to enrol 138 participants at 1 site."

Answered by AI

Are there any eligibility openings for this experiment?

"Affirmative. Clinicaltrials.gov confirms that this scientific endeavour, which was initially published on December 14th 2021, is presently searching for new participants. A total of 138 persons are needed to be enrolled from a solitary medical facility."

Answered by AI

What is the primary purpose of this research endeavor?

"This study will measure the Change in Perceived Stress Scale (PSS) over Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2). Secondary objectives are to gauge the Change in PTSD Checklist for Civilians (PCL-C), Insomnia Severity Index (ISI), and Generalized Anxiety Disorder-7's(GAD 7) severity."

Answered by AI