A Study Comparing Immediate Treatment to Deferred Treatment With the Fisher Wallace (FW) Stimulator FW-200 Device for the Treatment of Self-reported Anxiety in First Responders

Not Applicable

Completed

• Conditions: Anxiety

• Registration Number: NCT07093736
• Lead Sponsor: Fisher Wallace Laboratories

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.

Study Timeline

• Study Start: 2021-07-06
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Status Verified: 2025-07
• Study First Submitted: 2025-07-12
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.

Trial Locations

Locations (2)

Florence Healthcare; 🇺🇸 Atlanta, Georgia, United States

Seattle Police Department Wellness Unit; 🇺🇸 Seattle, Washington, United States