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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate treatment with FW-200 device

Group Type EXPERIMENTAL

FW-200

Intervention Type DEVICE

Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation

Deferred treatment with FW-200

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.

Group Type OTHER

FW-200

Intervention Type DEVICE

Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation

Interventions

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FW-200

Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No