PTSD Clinical Trial
Official title:
The Physiological, Psychological, and Cognitive Effects of Workplace Stress, SelfManagement Habits, and Irregular Shift Hours on First Responders
Verified date | December 2022 |
Source | Endominance |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
First Responders are expected to maintain high-performance levels under extreme conditions. However, constant intense workplace stress, physical work demands, and irregular shift hours are taking a severe toll on frontline workers. These demands often lead to physical and mental health problems, poor job performance, and lifestyle issues. Without better support and resources, these demands will continue to cause first responders to be trapped in a vicious cycle that typically includes occupational trauma, stress, and maladaptive coping skills. The purpose of this research is to: 1. Better understand the physiological, psychological, and cognitive impacts workplace stress and irregular shift hours have on first responders 2. Better understand the most prominent challenges first responders face when trying to manage their own physical and mental health. Through the results of this study, we hope to identify possible solutions/interventions at the individual, clinical and departmental levels to help first responders better manage their stress and improve their quality of life.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | May 1, 2023 |
Est. primary completion date | April 11, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Full-Time, actively employed First Responder - Participants must be 18 years of age and older - Participants must be able to read and write English - Participants must be able to provide consent independently - Participants must provide a legitimate postal address/P.O Box - Participants must have access to a device such as a computer or a smartphone Exclusion Criteria: - Unable to provide a stool sample due to health status or functional impairment - Unable to complete EEG measurement due to health status - Cognitively impaired persons - Department volunteers - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Endominance Inc. | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
Endominance | Dr. John J. Ratey, F1RST Clinic (Dr. Heather Twedell), HEM Pharma Inc., iMediSync |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbiome Analysis | Investigators will analyze participants' microbiomes to better understand diet habits and lifestyles. Enrolled participants will receive an at-home stool sample kit with instructions for the collection, storage, and shipping of samples. Samples will be lab processed and analyzed for the diversity of gut bacteria, dietary habits as well as gut microbiota-derived metabolites from exogenous dietary substrates and endogenous host compounds. Individual results will not be provided. | up to 3 months | |
Other | Health and Lifestyle survey | Demographic, health, and lifestyle data. | up to 3 months | |
Other | Depression Scores - Patient Health Questionnaire (PHQ-9) | PHQ-9 is a self-administered, 9-question diagnostic tool that rates depression using 9 DSM-V criteria for depression based on mood. Each of the 9 DSM-V criteria is scored as "0" (not at all) to "3" (nearly every day). Higher scores indicate greater severity of depressive symptoms. Individual results will not be provided. | up to 3 months | |
Other | Anxiety Scores - Generalized Anxiety Disorder (GAD-7) | GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 items include 1) nervousness; 2) inability to stop worrying; 3) excessive worry; 4) restlessness; 5) difficulty in relaxing; 6) easy irritation and 7 fear of something awful happening. Higher scores indicate greater severity of anxiety symptoms. Individual results will not be provided. | up to 3 months | |
Other | Post-traumatic stress syndrome (PTSD) - PCL-5 | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of post-traumatic stress syndrome (PTSD). Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4: "0" (not at all) to "4" (extremely). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 score between 31-33 is indicative of probable PTSD. Individual results will not be provided. | up to 3 months | |
Primary | aMCI (Amnestic Mild Cognitive Impairment) via Electroencephalogram (EEG) | Using an advanced wireless EEG device, PPG is measured using the following frequency bands for the prediction of aMCI: Absolute power of delta(1-4Hz), alpha1(8-10Hz), beta2(15-20Hz), beta3(20-30Hz), gamma(30-45Hz) and relative power-delta (1-4Hz), theta (4-8Hz), alpha1 (8-10Hz), alpha2 (10-12Hz), beta1 (10-15Hz), beta2(15-20Hz) and gamma(30-45Hz).
Specially trained machine learning algorithms can process quantitative EEG to identify subtle evidence of aMCI, thus enabling early interventions that have the greatest potential for delaying or preventing the progression of aMCI to Alzheimer's disease. Individual results will be provided. |
up to 3 months | |
Primary | Brain Functionality via Electroencephalogram (EEG) | PPG is measured using the following frequency bands for the prediction of brain functionality: Absolute power of delta(1-4Hz), alpha1(8-10Hz), beta2(15-20Hz), beta3(20-30Hz), gamma(30-45Hz) and relative power-delta (1-4Hz), theta (4-8Hz), alpha1 (8-10Hz), alpha2 (10-12Hz), beta1 (10-15Hz), beta2(15-20Hz) and gamma(30-45Hz).
3D brainwave analysis highlights the functional, rather than the structural, status of key brain areas, offering special insights into cortical dysfunction or compensatory activity. This brain map highlights areas where the balance between slow (theta, 4-8Hz) waves and fast (beta, 15-20Hz) waves differs from that expected based on age and sex-matched normal healthy population. Lower-than-expected levels of function are reported along with higher- than expected levels. Individual results will be provided. |
up to 3 months | |
Primary | ANS (Autonomic Nervous System) stress analysis via simultaneous Electroencephalogram (EEG) and HRV (heart rate variability) | The stress report analyzes ones PPG rhythm pattern with an AI algorithm, displaying 5 stages of stress from homeostasis to burnout (homeostasis, alarm, resistance, exhaustion, and burnout). HRV indicates balance between the activity of the two branches of the ANS.
Individual results will be provided. |
up to 3 months | |
Secondary | Cognitive Orientation & Social-Emotional Competency Assessment (COSEC) | An online cognitive propensity and behavioral preference diagnostic tool. COSEC is designed to understand people's various tendencies that occur during the process between perceiving the environment and responding in action. It illustrates an individual's personality and aptitude as an outcome shaped by their environment and the perception of the world around them. COSEC incorporates the environmental impact on the individual by looking at the unique process of a person's perception, conception, and behavior process. Assessments are scored using an algorithm to generate quantified measurements based on multifactorial relationships between a subject's responses.
Participants who complete the study will receive their personalized digital report called the COBI report. |
up to 3 months |
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