The Use of the CalmiGo Handheld Device in the Management of Patients With Anxiety and Panic Attack Symptoms in the Emergency Department

Generalized Anxiety-the display of excessive anxiety or worry for months-is associated with several anxiety-related symptoms including restlessness, feeling wound-up or on edge, being easily fatigued, difficulty concentrating, having the mind go blank, irritability, muscle tension, difficulty controlling worry, and sleep abnormalities [The National Institute]. Panic attacks-sudden periods of intense fear-include symptoms of palpitations, pounding heart, accelerated heart rate, sweating, trembling, shaking, sensations of shortness of breath, smothering, choking, and feelings of impending doom. Panic attacks are symptoms of Panic Disorder-an anxiety disorder with reoccurring and unforeseen episodes of panic attacks [The National Institute].

Typically, treatment consists of a combination of psychotherapy, Cognitive Behavioral Therapy (CBT), support groups, stress-management techniques, and anti-anxiety and/or anti-depressant medications. The caveat with these treatment options is that only anti-anxiety or anti-depressant medications are available as an early intervention option, especially in the ED. The use of anti-anxiety and anti-depressant medications in the treatment of Generalized Anxiety, panic attacks, and Panic Disorder in the ED provides challenges on multiple levels. For instance, some anti-depressants now carry a "black box warning" from the U.S. Food and Drug Administration making these drugs high risk with potentially serious health consequences. Therefore, the limited treatments options for the symptoms of Generalized Anxiety, panic attacks, and Panic Disorder in the ED raises the need for alternative, early intervention treatments.

This research study aims to use the CalmiGo handheld device in the ED to aide in the short term and long term care of patients presenting with anxiety and panic attack symptoms. The standard of care for treating anxiety and panic attack symptoms in the ED consists of CBT, anti-anxiety medications such as benzodiazepines, and referring patients for a psychiatry consult, if appropriate. Compared to current treatment options in the ED, CalmiGo is a relatively less expensive, longer acting, drug-free device that addresses many distress related symptoms of anxiety through a combination of exhalation prolongation, aromatherapy, and grounding techniques [CalmiGo]. This study does not aim to eliminate the need for medication or other combination therapies; however, CalmiGo can provide an alternative treatment option that can alleviate clinical presentations of anxiety and panic symptoms and can be used as an early intervention treatment option.

This study will be conducted through the administration of validated surveys, teaching the participating subject how to use the CalmiGo device, and letting patients use the CalmiGo device on their own.

Two screening tools that have been clinically shown to be effective forms of assessing Generalized Anxiety, panic attacks, and Panic Disorder will be used to assess patients' anxiety and panic attack symptoms: the Generalized Anxiety Disorder subscale (GAD-7) and the Panic Symptom Scale (PSS). The GAD-7 uses a 7-item anxiety scale as a quick and easy tool to identify patients with anxiety and to monitor treatment response [Spitzer], [Ebell]. Whereas the GAD-7 is self-reporting, the PSS is an interview-based scale to determine the severity of 13 different panic symptoms as outlined by the DSM-IV [Locke], [Fleet]. The two of these screening tools are able to provide a thorough evaluation of patient's anxiety and panic attack symptoms.