Anxiety Clinical Trial
Official title:
Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19
Verified date | May 2024 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Employed Healthcare workers aged 18 years and older. - Ability to comply with basic instructions and be able to sit still, comfortably during sessions. - Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, = 14). Exclusion Criteria: - Unable, unwilling, or incompetent to provide informed consent/assent. - 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 Home, or a wearable configuration of the same (B2, or B2v2). - Prior use of: 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) within one month before enrollment. - Known seizure disorder. - Thoughts of suicide within the last 3 months. - Current, significant symptoms of long-COVID. - Current medical student. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | The Susanne Marcus Collins Foundation, Inc |
United States,
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* Note: There are 67 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Center for Epidemiologic Studies Depression Scale (CES-D) | The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Posttraumatic stress disorder (PTSD) Checklist for Civilians (PCL-C) | The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Fatigue Severity Scale (FSS) | Fatigue Severity Scale (FSS) is a nine-item instrument to assess how fatigue interferes with daily activities. Items are scored on a 7-point scale ranging from 1=strongly disagree to 7=strongly agree. Total scores range from 9 to 63 and the higher the rating demonstrates greater fatigue severity . | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Quality of Life Scale (QOLS) | The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112). | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Interpersonal Support Evaluation List (ISEL-12) | The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Multiple Ability Self-Report Questionnaire (MASQ) | The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in The Depression, Anxiety, and Stress Scale (DASS-21) | The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report scale with 21 items(Le et al., 2019; D. Lee, 2019). These questions are divided into three subscales to depression, anxiety, and stress, respectively. The depression subscale scoring ranges from normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27, and extremely severe depression (28-42). The anxiety subscale scoring ranges from normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). The stress subscale ranges from normal (0-10), mild stress (11-18), moderate stress (19-26), sever stress (27-34), and extremely severe stress (35-42). This scale is routinely used in COVID-19 (Wang et al., 2020) and SARS literature(McAlonan et al., 2007). | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Heart Rate Variability (HRV) | Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Other | Change in Heart Rate (HR) | Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed. | Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Primary | Change in Perceived Stress Scale (PSS) | 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 | |
Primary | Change in Perceived Stress Scale (PSS) | 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. | Visit 2 (0-7 days after final session) | |
Primary | Change in Perceived Stress Scale (PSS) | 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. | Visit 3 (4-6 weeks after V2) | |
Secondary | Change in Insomnia Severity Index (ISI) | 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, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) | |
Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) | 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, V2 (0-7 days after final session), and V3 (4-6 weeks after V2) |
Status | Clinical Trial | Phase | |
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