Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale (PSS) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Cereset Research Tune-Up Intervention Group
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.
干预措施: Cereset Research (Device)
Cereset Research Control Group
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.
干预措施: Cereset Research (Device)
结局指标
主要结局
Change in Perceived Stress Scale (PSS) Scores
时间窗: Baseline to year 1
The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.
次要结局
- Change in Insomnia Severity Index (ISI) Scores(Baseline to year 1)
- Change in Generalized Anxiety Disorder-7 (GAD-7) Scores(Baseline to year 1)