Using CalmiGo to Manage Anxiety and Panic Attack Symptoms in the Emergency Department

NCT03884712 | Completed

• 1 other identifier: 19-0033
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are limited options in the management of anxiety and panic attack symptoms in the Emergency Department (ED). The most common treatment method is the use of anti-anxiety and anti-depressant medications; however, these drugs have serious health risks which make them ineffective as a long-term treatment option. The CalmiGo handheld device, formerly known as "myReLeaf", provides an alternative early intervention option in treating patients presenting with anxiety and panic attack symptoms by using guided breathing, aromatherapy, and grounding techniques. The hypothesis of this study is that CalmiGo will provide a drug-free, early intervention, and long-term treatment option in the ED that will improve patients' anxiety and panic attack symptoms. Patients who present to the ED with anxiety or panic attack symptoms will be considered eligible for this study. These patients will be approached, and they will give informed consent to participate in the study. Patients will be enrolled in the study which consists of completing validated surveys asking about their anxiety and panic symptoms, using CalmiGo, and allowing investigators to access their medical records. These surveys will be completed before and after using CalmiGo in the ED to measure the presence and severity of anxiety and panic symptoms. The goal of this study is to analyze the effectiveness of using CalmiGo to improve anxiety and panic attack symptoms based on validated survey responses. Overall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with anxiety or panic attack symptoms.

Conditions

Anxiety; Panic Attacks

Keywords

anxiety symptoms; panic attack symptoms; emergency department; CalmiGo

Outcome Measures

Primary Outcomes (1)

• Change in presentation and severity of anxiety and panic symptoms

  Panic Symptom Scale (PSS) survey responses before using CalmiGo will be compared to the PSS survey responses after using CalmiGo. The PSS rates the severity of 13 panic symptoms on a scale of 0 to 4; a rating of 0 indicates that the symptom is not present and a rating of 4 indicates that the symptom is extremely severe. The sum of all the ratings for the 13 symptoms on the PSS (raw score) represents the overall severity of the patient's panic state. A lower raw score indicates a lesser severity of symptoms and a higher raw score indicates a higher severity of symptoms. If a patients raw score decreases after using CalmiGo, this would indicate an improvement in anxiety and panic attack symptoms and would indicate the effectiveness of using CalmiGo to treat anxiety and panic attack symptoms.

  1 year

Secondary Outcomes (1)

• Change in presentation and severity of anxiety and panic attack symptoms between patients who use and patients who do not use medications to treat anxiety or panic attacks

  1 year

Study Arms (1)

CalmiGo Recipients

EXPERIMENTAL

This arm will receive a CalmiGo handheld device during their participation in the study. Participants will first complete validated surveys assessing their anxiety and panic attack symptoms. Investigators will then demonstrate how to use the CalmiGo handheld device. Participants will use the device with the investigator and then participants will use the device on their own for at least 2 times. After using CalmiGo, participants will complete validated surveys reassessing their anxiety and panic attack symptoms, asking about their past medical history, and inquiring about their experience using CalmiGo.

Device: CalmiGo

Interventions

CalmiGo DEVICE

The CalmiGo handheld device is a device of similar size to an inhaler that uses guided breathing, aromatherapy and grounding techniques to regulate breathing to bring users a sense of calm and relaxation. The CalmiGo handheld device is being tested in this study to alleviate participants' anxiety and panic attack symptoms.

Also known as: myReLeaf

CalmiGo Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the LHH Emergency Department (ED)
• Presenting with anxiety and panic attack symptoms (confirmed by ED provider)
• Able to provide informed consent
• Must be aged 18 years or older

You may not qualify if:

• Pregnant patients
• Patients less than 18 years of age
• Prisoners
• Cognitively impaired.
• Asthma
• Chief obstructive pulmonary disorder (COPD)
• Bi-polar disorder
• Psychosis or delusional disorders
• History of substance abuse or dependence
• History of being suicidal
• Organic mental disorder
• Severe unstable medical illness
• Chronic respiratory disease
• History of seizures.

Sponsors & Collaborators

• Yves Duroseau: lead
• Dendro Technologies, Inc: collaborator

Study Sites (1)

Lenox Hill Hospital

Manhattan, New York, 10075, United States

Location

Related Publications (4)

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Ebell MH. Diagnosis of anxiety disorders in primary care. Am Fam Physician. 2008 Aug 15;78(4):501-2. No abstract available.

  PMID: 18756659 BACKGROUND

• Fleet R, Foldes-Busque G, Gregoire J, Harel F, Laurin C, Burelle D, Lavoie K. A study of myocardial perfusion in patients with panic disorder and low risk coronary artery disease after 35% CO2 challenge. J Psychosom Res. 2014 Jan;76(1):41-5. doi: 10.1016/j.jpsychores.2013.08.003. Epub 2013 Aug 15.

  PMID: 24360140 BACKGROUND

• Locke AB, Kirst N, Shultz CG. Diagnosis and management of generalized anxiety disorder and panic disorder in adults. Am Fam Physician. 2015 May 1;91(9):617-24.

  PMID: 25955736 BACKGROUND

Related Links

• The National Institute of Mental Health. "Anxiety Disorders". The National Institute of Mental Health, U.S. Department of Health and Human Services.
• CalmiGo. "The Science Behind CalmiGo".

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Emergencies

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves Duroseau, MD

  Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Emergency Medicine, Lenox Hill Hospital

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: August 7, 2019
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)