Clinical trial NCT05659277: The Effects of Stress & Irregular Shift Hours on First Responders
Official title: The Physiological, Psychological, and Cognitive Effects of Workplace Stress, SelfManagement Habits, and Irregular Shift Hours on First Responders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Workplace Stress
Mental Health
HRV
EEG
PTSD
Keywords: First Responder
Shift Work
PHQ9
GAD7
Lead sponsor: Endominance
Sponsor class: INDUSTRY
Collaborators: name: Dr. John J. Ratey
name: F1RST Clinic (Dr. Heather Twedell)
name: HEM Pharma Inc.
name: iMediSync
First posted: 2022-12-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First Responders including firefighters, police, SWAT, EMTs, detectives, and dispatchers.

Brief summary: 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.

Detailed description: This study aims to expand and improve current research regarding the physiological, psychological, and cognitive impacts that workplace stress and irregular shift hours have on first responders. The investigators will examine electroencephalogram (EEG)/heart rate variability (HRV) measurements and gut microbiota to help bridge the connection between the impacts of a physically and mentally demanding workplace with highly irregular shift hours on first responders. There are numerous studies conducted to evaluate how stress impacts first responders in areas such as physical and mental health, but there lacks comprehensive research that examines the physiological, psychological, and cognitive impacts of workplace stress and irregular shift hours have on first responders in the U.S.

There also lacks information of the challenges first responders face when trying to manage their physical and mental health. To conduct these objectives, we will focus on these specific aspects:

1. The impact of shift hours (especially longer shift hours, e.g., firefighters 24 vs. 48 shift hours) on first responders, specifically in connection to sleep disorders and other cognitive function-related issues.
2. The connection between workplace incidents and stress/alertness levels - even during off-duty hours.
3. First responder self-help/stress relief coping techniques or modalities and their efficacy

Eligibility criteria: 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

Primary outcomes:
measure: aMCI (Amnestic Mild Cognitive Impairment) via Electroencephalogram (EEG)
timeFrame: up to 3 months
measure: Brain Functionality via Electroencephalogram (EEG)
timeFrame: up to 3 months
measure: ANS (Autonomic Nervous System) stress analysis via simultaneous Electroencephalogram (EEG) and HRV (heart rate variability)
timeFrame: up to 3 months
Secondary outcomes:
measure: Cognitive Orientation & Social-Emotional Competency Assessment (COSEC)
timeFrame: up to 3 months
Other outcomes:
measure: Microbiome Analysis
timeFrame: up to 3 months
measure: Health and Lifestyle survey
timeFrame: up to 3 months
measure: Depression Scores - Patient Health Questionnaire (PHQ-9)
timeFrame: up to 3 months
measure: Anxiety Scores - Generalized Anxiety Disorder (GAD-7)
timeFrame: up to 3 months
measure: Post-traumatic stress syndrome (PTSD) - PCL-5
timeFrame: up to 3 months
Locations:
city: Irvine
country: United States
facility: Endominance Inc.
state: California
Study officials:
References: