Clinical trial NCT05994261: Cereset Research Long-Term Healthcare Worker Study
Official title: Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Autonomic Dysregulation
Acoustic Stimulation
Hyperarousal
Health Personnel
Keywords: stress
anxiety
insomnia
Cereset Research
hyperarousal
brain electrical activity
autonomic dysregulation
neurotechnology
HIRREM
allostasis
neuromodulation
acoustic stimulation
COVID-19
healthcare worker
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Susanne Marcus Collins Foundation, Inc.
First posted: 2023-08-16
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.

Detailed description: This randomized, controlled study will evaluate the effects of long-term Cereset Research maintenance intervention in healthcare workers with symptoms of stress in the post era of COVID-19. Healthcare workers of all types have been impacted personally, professionally, and financially by the pandemic and its aftermath, resulting in higher levels of stress and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the effects of the acute trauma associated with the pandemic. The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived stress in the Intervention group compared to the Control Group. Data will also be collected on a variety of additional relevant symptoms including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits have been shown in prior studies using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of long-term maintenance intervention versus control. The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed. The Control Group continues current care with no additional CR sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would suggest benefit for long-term maintenance intervention sessions. The effect of this approach on autonomic function and other self-reported symptoms will also be explored. This information will be useful for determining intervention schedules for direct clinical implementation of the intervention. The proposed study might also help to identify characteristics of individuals who may experience differential effects/benefits from application of CR and determine if intermittent "tune-up" sessions may prolong symptom improvement.

Eligibility criteria: Inclusion Criteria:

* Employed healthcare workers aged 18 years and older.
* Have availability and interest in participating in a 1 year study.
* Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
* Experiencing symptoms of stress meeting threshold score on the Perceived Stress Scale (PSS ≥ 14).

Exclusion Criteria:

* No internet access, as some visits collected electronically
* Unable, unwilling, or incompetent to provide informed consent.
* 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 Research, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
* Prior use of the following modalities within one month before enrollment: 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).
* Known seizure disorder.
* Thoughts of active suicide within the last 3 months.
* Current medical student.

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS) scores
timeFrame: Baseline to year 1
Secondary outcomes:
measure: Change in Insomnia Severity Index (ISI) scores
timeFrame: Baseline to year 1
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) scores
timeFrame: Baseline to year 1
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References: