University of Nebraska Medical Center researchers Lauren Edwards, MD, UNMC Department of Psychiatry and Justin Weeks, PhD, Nebraska Medicine Department of Psychology, are seeking 30 participants with generalized anxiety disorder to test a non-invasive device (IRB#: 147-21-FB). There will be two to three in-person clinic visits.
Anxiety disorders are the most common mental health disorders. UNMC and Nebraska Medicine are studying a device called the Empower Neuromodulation System (Empower) as a possible treatment for generalized anxiety disorder (GAD).
The Empower device delivers an electronic stimulation to nerves under the skin, causing an effect similar to acupuncture techniques. The wearer may feel a tingling sensation. The device is made of a controller, electrodes, and extension cable. Information is collected on a smartphone through an app. The Empower device may help people manage their anxiety.
The goals of this study are to evaluate the acceptability and effectiveness of the Empower device.
The study is seeking adults who are:
- 19 years and older.
- Have generalized anxiety disorder.
- Are not pregnant or breastfeeding and have not been pregnant in the last six months.
- Able to participate for six weeks.
Participants will be evaluated to confirm the diagnosis of GAD and get baseline measurements of current anxiety symptoms. Participants will receive both the Empower device and a smartphone. Participants will be randomly assigned to either active treatment or "sham" (fake) treatment. They will wear the device twice a day for 30 minutes each time. Participants will be asked to evaluate the use of the device as a treatment for GAD and complete surveys related to anxiety, medication use, treatment satisfaction and usability of the device. There will be two to three in-person clinic visits.
This study could lead to the Empower device being a valuable non-medication therapy for anxiety.
Those interested in participating can contact: Gage Walker at 402-552-2475 or gagwalker@unmc.edu
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