Anxiety Clinical Trial
— LT-HWOfficial title:
Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | November 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Atrium Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Susanne Marcus Collins Foundation, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Perceived Stress Scale (PSS) scores | The Perceived Stress Scale (PSS) 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. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress. | Baseline to year 1 | |
Secondary | Change in Insomnia Severity Index (ISI) scores | 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 | |
Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) scores | The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety. | Baseline to year 1 |
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