Anxiety, Generalized Anxiety, Generalized Anxiety Disorder
Conditions
Brief summary
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.
Interventions
DEVICECranial Electrotherapy Stimulator (CES) Device
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
Sponsors
Fisher Wallace
ProofPilot
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than 21 * US resident * Can receive packages to their home via UPS/Fedex/USPS * Licensed Physician Diagnosis of Generalized Anxiety Disorder * Beck Anxiety Inventory Score between 8 and 25 * Read/write English * Have not contemplated suicide in the past year * Not been institutionalized for mental health issues. * Not currently experiencing problems with alcohol or drug abuse * Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study * Can commit to two (2) 20 minute sessions per day for 8 weeks * Not under medical supervision for serious medical condition * Not currently being treated for or suspect a mental health issue * Has not used a brain stimulation treatment in one year * No suspected or known history of heart disease * No pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc. * Not taking opioids * Are a resident of states in which we have licensed medical professionals * Does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion. * Does not use any illicit drugs * Not participating in any other anxiety study * Not taking medications affecting the nervous system (e.g. psychiatric medications) * Not taking hypnotics or any sleep aid or marijuana (in any form)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beck Anxiety Inventory (BAI) Score | baseline versus week 4 | The Beck is a 21 item self-reported scale measuring anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Promise Sleep-SD | baseline versus week 4 | Change in self reported sleep quality |
| Change in Patient Health Questionnaire - 8 (PHQ-8) | baseline versus week 4 | self reported depression symptoms |
| Change in Beck Anxiety Inventory (BAI) Score | week 4 versus week 8 | The Beck is a 21 item self-reported scale measuring anxiety |
| Device safety, tolerability and adherence as measured by SAFTEE | baseline versus week 8 | The SAFTEE is a self reported measure of side effects associated with mental health treatments |
Countries
United States
Outcome results
None listed