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出境医 / 临床实验 / Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?

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

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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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 : December 19, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : June 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Keith Lambert, MD 7206294136 KLambert@asecnsion.org

Locations
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United States, Texas
University of Texas Austin Recruiting
Austin, Texas, United States, 78701
Contact: Keith Lambert, MD    720-629-4136 ext 7206294136    KLambert@asecnsion.org   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Keith Lambert, MD University of Texas at Austin
Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 24, 2019
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • Change in depression score [ Time Frame: 90 and 180 days ]
    Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
  • Change in anxiety score [ Time Frame: 90 and 180 days ]
    Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
  • Change in stress levels [ Time Frame: 90 and 180 days ]
    Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
  • Change in burnout level [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Change in depression score [ Time Frame: 90 and 180 days ]
    Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
  • Change in anxiety score [ Time Frame: 90 and 180 days ]
    Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
  • Change in stress levels [ Time Frame: 90 and 180 days ]
    Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
  • Change in burnout level [ Time Frame: 90 and 180 days ]
    Maslach Burnout Inventory, measures level of stress on a numeric scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Official Title  ICMJE Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, non-blinded, control trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Burnout, Professional
  • Depression
  • Anxiety
  • Stress
Intervention  ICMJE Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers
Phone-based meditation application
Study Arms  ICMJE
  • No Intervention: Control
  • Active Comparator: Intervention
    Intervention: Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811990
Other Study ID Numbers  ICMJE 2018-04-0089
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Lambert, MD University of Texas at Austin
PRS Account University of Texas at Austin
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP