Cereset Research Langsigtet Healthcare Worker Study (LT-HW)
Evaluering af langsigtet gennemførlighed af Cereset-forskning for stressede sundhedsarbejdere
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27104
- Atrium Wake Forest Baptist Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions. |
|
Andet: 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. |
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Perceived Stress Scale (PSS) Scores
Tidsramme: 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. |
Baseline to year 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Insomnia Severity Index (ISI) Scores
Tidsramme: Baseline to year 1
|
The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia. |
Baseline to year 1
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
Tidsramme: Baseline to year 1
|
The Generalized Anxiety Disorder-7 is a seven-item screening tool for anxiety, with answer ranging from 0-3, yielding total scores from 0-21. This is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety. |
Baseline to year 1
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Charles H Tegeler, MD, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Psykiske lidelser
- Luftvejsinfektioner
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Luftvejssygdomme
- Lungesygdomme
- Søvnvågningsforstyrrelser
- Lungebetændelse, viral
- Lungebetændelse
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- Søvnforstyrrelser, iboende
- Dyssomnier
- Sygdomme i det autonome nervesystem
- COVID-19
- Angstlidelser
- Søvninitiering og vedligeholdelsesforstyrrelser
- Primære dysautonomier
Andre undersøgelses-id-numre
- IRB00099972
Plan for individuelle deltagerdata (IPD)
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