Cereset Intervention for Stress and Anxiety

(LT-HW Trial)

Overseen By Charles H Tegeler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe hearing impairment, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

94 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What data supports the effectiveness of the Cereset treatment for stress and anxiety?

The research on cognitive behavioral stress management for breast cancer patients shows that such interventions can improve coping skills and reduce stress-related symptoms. This suggests that treatments like Cereset, which aim to manage stress and anxiety, may also be effective in enhancing coping strategies and reducing stress. ^{1 2 3 4 5}

How is the Cereset treatment for stress and anxiety different from other treatments?

Cereset is unique because it uses a non-invasive method called BrainEcho or HIRREM, which involves listening to brainwave echoes to help the brain relax and reset itself, unlike traditional treatments that may involve medication or talk therapy. ^{6 7 8 9 10}

Research Team

Charles H Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

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 experiencing high levels of stress.

Exclusion Criteria

No internet access, as some visits collected electronically

I have a known seizure disorder.

I cannot sit comfortably for up to an hour or attend study visits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

All participants receive an initial 4-session Cereset Research intervention

4 weeks

4 visits (in-person)

Maintenance Intervention

Intervention group receives a maintenance session every 6 weeks for one year

48 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in stress, insomnia, and anxiety over one year

52 weeks

Treatment Details

Interventions

• Cereset Research

Trial Overview 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.

Participant Groups

Group I: Cereset Research Control Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Susanne Marcus Collins Foundation, Inc.

Collaborator

Trials

5

Recruited

430+

Susanne Marcus Collins Foundation, Inc.

Collaborator

Trials

2

Recruited

130+

Findings from Research

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.

Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]

A computer biofeedback game was developed to teach deep relaxation to 40 patients with irritable bowel syndrome (IBS), and most participants achieved deeper relaxation after just four 30-minute sessions, indicating the game's effectiveness in promoting relaxation.

About 50% of patients reported that using the relaxation technique during symptom flare-ups helped reduce their overall and bowel-specific symptoms, and 64% continued to use the technique long-term, suggesting its potential as a sustainable management strategy for stress-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised biofeedback games: a new method for teaching stress management and its use in irritable bowel syndrome. Leahy, A., Clayman, C., Mason, I., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Distinct Stress Profiles Among Oncology Patients Undergoing Chemotherapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Relaxation and imagery in the treatment of breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Group Intervention on Enhancing Cognitive Emotion Regulation Strategies in Breast Cancer Patients: A 2-Year Follow-up. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. [2022]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of cereton in the rehabilitation of patients with hemorrhagic stroke]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Lowering stress while teaching research: a creative arts intervention in the classroom. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Stress and anxiety. [2005]

9. England pubmed.ncbi.nlm.nih.gov

Computerised biofeedback games: a new method for teaching stress management and its use in irritable bowel syndrome. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Biofeedback to treat anxiety in young people at clinical high risk for developing psychosis. [2019]