The goal of this clinical trial is to learn if the Fisher Wallace Stimulator FW-200 experimental device is effective at treating self-reported anxiety in first responders. The main question the trial aims to answer is does the FW-200 device improve anxiety as measured by a validated questionnaire.
This is a randomized waitlist-controlled trial to evaluate the efficacy and safety of the Fisher Wallace Stimulator FW-200 device in the treatment of self-reported anxiety in police personnel and first responders. Participants will be randomly assigned to receive immediate treatment or deferred treatment with the FW-200 device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation
Florence Healthcare
Atlanta, Georgia, United States
Seattle Police Department Wellness Unit
Seattle, Washington, United States
Beck Anxiety Inventory (BAI) scores
Change in Beck Anxiety Inventory (BAI) scores at Week 2 versus baseline in immediate treatment group compared to the deferred treatment group. Total score range is a minimum of 0 to a maximum of 63. Higher score means a worse severity of anxiety.
Time frame: From baseline to week 2
Patient Health Questionnaire
Change in Patient Health Questionnaire-8
Time frame: From baseline to week 2 and week 4. Total scores range from 0 to 24. Higher scores mean worse severity of depressive symptoms.
Professional Quality of Life
Change in Professional Quality of Life
Time frame: From baseline to week 2 and week 4
Consenting to Study Continuation
Percentage of participants consenting to study continuation at week 4 in the immediate treatment group compared to deferred treatment group
Time frame: Week 4
Total Sleep Time
Percentage of participants with a 20 minute or more increase in total sleep time for the immediate treatment group compared to the deferred treatment group.
Time frame: Baseline to through study completion
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