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

Primary Purpose

Burnout, Professional, Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cleveland Clinic Stress Free Now Meditations For Healers
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Professional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in depression score
Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
Change in anxiety score
Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
Change in stress levels
Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
Change in burnout level
Maslach Burnout Inventory, measures level of stress on a numeric scale

Secondary Outcome Measures

Full Information

First Posted
January 16, 2019
Last Updated
January 22, 2019
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03811990
Brief Title
Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Official Title
Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Depression, Anxiety, Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, non-blinded, control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cleveland Clinic Stress Free Now Meditations For Healers
Intervention Description
Phone-based meditation application
Primary Outcome Measure Information:
Title
Change in depression score
Description
Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
Time Frame
90 and 180 days
Title
Change in anxiety score
Description
Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
Time Frame
90 and 180 days
Title
Change in stress levels
Description
Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
Time Frame
90 and 180 days
Title
Change in burnout level
Description
Maslach Burnout Inventory, measures level of stress on a numeric scale
Time Frame
90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Lambert, MD
Phone
7206294136
Email
KLambert@asecnsion.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Lambert, MD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Lambert, MD
Phone
720-629-4136
Ext
7206294136
Email
KLambert@asecnsion.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26993534
Citation
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.
Results Reference
background

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

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