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Behavioural Intervention
Cereset Intervention for Stress and Anxiety (LT-HW Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to year 1
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if regular Cereset sessions can help healthcare workers reduce stress after COVID-19. The treatment uses sound to help the brain relax and reset itself. The goal is to see if these sessions can lower stress levels compared to usual care.
Who is the study for?
This trial is for healthcare workers over 18 who feel stressed (PSS score ≥ 14), can follow instructions, sit still for sessions, and commit to a year-long study. It's not for those without internet, severe hearing issues, over 400 pounds, using certain brain therapies recently or enrolled in another study.
What is being tested?
The trial tests long-term effects of 'Cereset Research', an acoustic stimulation therapy after initial sessions versus usual care. Participants are randomly assigned to either continue with the therapy or receive standard care after their first four sessions.
What are the potential side effects?
Since this intervention involves non-invasive acoustic stimulation, side effects may be minimal but could include discomfort from wearing earbuds or sitting still during sessions. Specific side effects aren't detailed but would likely relate to sensory experiences.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to year 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Perceived Stress Scale (PSS) scores
Secondary study objectives
Change in Generalized Anxiety Disorder-7 (GAD-7) scores
Change in Insomnia Severity Index (ISI) scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cereset Research Control GroupExperimental Treatment1 Intervention
All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.
Group II: Cereset Research Tune-Up Intervention GroupActive Control1 Intervention
All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cereset Research
2021
N/A
~150
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neurofeedback technology, such as Cereset, works by providing real-time feedback on brainwave activity, enabling individuals to self-regulate and optimize their brain function. This is particularly beneficial for healthcare workers who face high stress and burnout.
By enhancing cognitive performance and emotional regulation, neurofeedback helps improve overall well-being, allowing healthcare workers to better manage their demanding responsibilities and maintain their mental health.
A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study.
A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,357 Previous Clinical Trials
1,031,596 Total Patients Enrolled
Susanne Marcus Collins Foundation, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Charles H Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known seizure disorder.I cannot sit comfortably for up to an hour or attend study visits.I am available and interested in joining a study for 1 year.I am an employed healthcare worker and I am 18 years or older.I am unable to give informed consent for the trial.I have used HIRREM, BWO, Cereset, or similar brainwave optimization technologies.I haven't had specific brain treatments like ECT or TMS in the last month.I weigh more than 400 pounds.I am experiencing high levels of stress.I can follow simple instructions and sit still comfortably.
Research Study Groups:
This trial has the following groups:- Group 1: Cereset Research Tune-Up Intervention Group
- Group 2: Cereset Research Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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