Anxiety
Conditions
Keywords
self-reported anxiety, first responder
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFW-200
Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation
Sponsors
Advarra
Florence Healthcare
Fisher Wallace Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study was a waitlist-controlled study where the subjects were randomly assigned to receive an intervention immediately or after a specified delay. The two-week delay was designed to measure the natural progression of anxiety symptoms over a short period without intervention and to establish a baseline for how rapidly symptoms may escalate or impair functioning.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Ability to read and write in English * First responder employee or employee of participating police department * Beck Anxiety Inventory total score above 7 * Able to commit to two 20-minute device treatment session per day for up to 8 weeks * Willing to wear an actigraphy device
Exclusion criteria
* Use of brain stimulation device in the last year * Have a pacemaker, electronic stent or electronic implants * Started or planning to start new medial treatment or health program over the next 8 weeks * Contemplated suicide in the past year * Institutionalized for mental health issues * Have a serious medical condition * Currently taking medications affecting the nervous system * Allergic to nickel * Currently taking or planning to take part in any other study on insomnia, anxiety or other mental health effort over the next 8 weeks * Currently pregnant or planning to become pregnant in the next 10 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) scores | From baseline to week 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire | From baseline to week 2 and week 4. Total scores range from 0 to 24. Higher scores mean worse severity of depressive symptoms. | Change in Patient Health Questionnaire-8 |
| Professional Quality of Life | From baseline to week 2 and week 4 | Change in Professional Quality of Life |
| Consenting to Study Continuation | Week 4 | Percentage of participants consenting to study continuation at week 4 in the immediate treatment group compared to deferred treatment group |
| Total Sleep Time | Baseline to through study completion | 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. |
Countries
United States
Outcome results
None listed