Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03811990
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.4
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs.

Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.

Condition or Disease	Intervention/Treatment	Phase
Burnout, Professional; Depression; Anxiety; Stress	Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, non-blinded, control trialRandomized, non-blinded, control trial
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
• Actual Study Start Date: Dec 19, 2018
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Active Comparator: Intervention	Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers; Phone-based meditation application

Outcome Measures

Primary Outcome Measures

1. Change in depression score [90 and 180 days]

   Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed

2. Change in anxiety score [90 and 180 days]

   Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious

3. Change in stress levels [90 and 180 days]

   Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed

4. Change in burnout level [90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score]

   Maslach Burnout Inventory, measures level of stress on a numeric scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse

• Age greater than/equal to 18 years old and younger than 75 years old

• Must own a mobile phone operating on the iOS system

Exclusion Criteria:

• Already use a phone-based meditation app on a weekly basis

• Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Austin	Austin	Texas	United States	78701

Sponsors and Collaborators

• University of Texas at Austin

Investigators

• Principal Investigator: Keith Lambert, MD, University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

• Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15. Review.

• Responsible Party: University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03811990
• Other Study ID Numbers: 2018-04-0089
• First Posted: Jan 22, 2019
• Last Update Posted: Jan 24, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies; Burnout, Professional

Study Results

No Results Posted as of Jan 24, 2019