Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 20-minute per day treatment sessions over eight weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
ProofPilot (Remote Virtual Trial)
New York, New York, United States
Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety
Time frame: baseline versus week 4
Change in Promise Sleep-SD
Change in self reported sleep quality
Time frame: baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)
self reported depression symptoms
Time frame: baseline versus week 4
Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety
Time frame: week 4 versus week 8
Device safety, tolerability and adherence as measured by SAFTEE
The SAFTEE is a self reported measure of side effects associated with mental health treatments
Time frame: baseline versus week 8
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