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| Name | Class |
|---|---|
| Advarra | INDUSTRY |
| Florence Healthcare | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment with FW-200 device | Experimental |
| |
| Deferred treatment with FW-200 | Other | FW-200 treatment was delayed for two-weeks 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FW-200 | Device | Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire | Change in Patient Health Questionnaire-8 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lois James, Ph.D. | James Consulting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florence Healthcare | Atlanta | Georgia | 30308 | United States | ||
| Seattle Police Department Wellness Unit |
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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.
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Change in Professional Quality of Life
| 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 | 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. | Baseline to through study completion |
| Seattle |
| Washington |
| 98104 |
| United States |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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