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Meditation for Burnout in PA Students

Primary Purpose

Burnout, Student, Feasibility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calm Meditation
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Student

Eligibility Criteria

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

Inclusion Criteria:

  • Physician assistant students currently enrolled in school who do not practice meditation regularly
  • > 18 years of age
  • Able to speak/read/understand English
  • Residing in the U.S.
  • Regular internet access via mobile phone, tablet, etc.
  • Willing to participate in app-based meditation program
  • Burnout, classified as a score greater than or equal to 3 on the non-propriety single item burnout measure.

Exclusion Criteria:

  • Physician assistant students who currently (within the last six months) practice meditation
  • Professionals who identify as a practicing physician assistant
  • People who are not currently enrolled in physician assistant school
  • Individuals who are not burnt out, classified as a score less than or equal to 2 on the non-propriety single item burnout measure.

Sites / Locations

  • Arizona Biomedical Collaborative

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calm

Waitlist

Arm Description

Participants will be asked to download the Calm app on their smartphone. Participants will then receive an email containing login credentials to access the Calm app. Once they receive this email and they receive their study start date, they will be asked to meditate for at least 10 minutes a day for 8 weeks. This prescription mimics how a new, paying member would use the app. Participants in the intervention group will be emailed weekly reminders.

Participants randomized to the control group will be asked to maintain their normal routine for 8 weeks and to avoid using the Calm meditation app.

Outcomes

Primary Outcome Measures

Burnout
The Maslach Burnout Inventory is a 22-item inventory used to measure aspects of the burnout syndrome within three subscales: emotional exhaustion, depersonalization, and personal accomplishment. Using a seven-point scale (0, never; 1, a few times per year; 2, once a month; 3, a few times a month; 4, once a week; 5, a few times a week; 6, every day), participants rate their experience of burnout. Possible scores on the emotional exhaustion subscale range from 0 to 54. Possible scores on the depersonalization subscale range from 0 to 30. For both the emotional exhaustion and depersonalization subscales, higher mean scores correspond to higher degrees of burnout. Possible scores on the personal accomplishment subscale range from 0 to 48. Lower mean scores on the personal accomplishment subscale correspond to higher degrees of burnout. Scores are computes via sum.

Secondary Outcome Measures

Mindfulness
The Freidburg Mindfulness Inventory is used to measure mindfulness using a 14-item questionnaire covering all aspects of mindfulness. Using a four-point scale, (1, rarely; 2, occasionally; 3, fairly often; 4, almost always), participants are asked to characterize their experience of mindfulness. Higher scores indicate higher levels of mindfulness. Scores are computed via sum.
Stress
The Perceived Stress Scale is a 10-item inventory used for the assessment of perceived stress. The scale measures the degree to which situations are appraised as stressful. The items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate higher levels of stress. Scores are computed via sum.
Depression
The Patient Health Questionnaire-9 is used to measure and diagnose depression using a 9-item self-report measure. Items are rated 4-item scale ranging from 0 (Not at all) to 3 (nearly every day). Higher scores correspond with more severe depressive symptoms. Scores are computed via sum.

Full Information

First Posted
November 18, 2019
Last Updated
April 21, 2020
Sponsor
Arizona State University
Collaborators
Calm.com, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04169724
Brief Title
Meditation for Burnout in PA Students
Official Title
Feasibility of The Mindfulness Meditation App "Calm" to Reduce Burnout in Physician Assistant Students
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Calm.com, Inc.

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
This study investigates the feasibility and effects of an app-based mindfulness meditation intervention for PA students.
Detailed Description
The purpose of this study is to determine the feasibility of an app-based mindfulness meditation intervention for PA students. The investigators will measure feasibility of using the Calm app for 10-minutes a day for four weeks in PA students. Feasibility will be measured with acceptability (i.e. satisfaction survey), demand (participation in the app as prescribed), and practicality (i.e., survey). Secondly, the investigators will determine the preliminary effects of a 4-week meditation intervention on burnout levels in PA students when compared to a wait list control group. Burnout symptoms (primary outcome), mindfulness, stress levels, and depressive symptoms (secondary outcomes) will be measured at baseline and post-intervention (4-weeks). Data gathered from this study will inform a future randomized controlled trial to determine the effects of a mindfulness meditation app on burnout in PA students. The information could also be used to design other studies assessing burnout in the workplace. Aim 1: Determine the feasibility (acceptability, demand, practicality) of using the Calm app 10-minutes per day for four weeks in PA students. For the intervention group, our benchmarks will be as follows: 1) Acceptability (i.e., satisfaction) ≥70%, 2) Demand (i.e., participation in the app as prescribed, intention to use) ≥70%, 3) Practicality (i.e., survey) ≥70%. Aim 2: Determine the preliminary effects of using the Calm app 10-minutes per day for four weeks on burnout (primary outcome) mindfulness, stress levels, and depressive symptoms (secondary outcomes) in PA students as compared to a wait-list control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Student, Feasibility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calm
Arm Type
Experimental
Arm Description
Participants will be asked to download the Calm app on their smartphone. Participants will then receive an email containing login credentials to access the Calm app. Once they receive this email and they receive their study start date, they will be asked to meditate for at least 10 minutes a day for 8 weeks. This prescription mimics how a new, paying member would use the app. Participants in the intervention group will be emailed weekly reminders.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will be asked to maintain their normal routine for 8 weeks and to avoid using the Calm meditation app.
Intervention Type
Behavioral
Intervention Name(s)
Calm Meditation
Intervention Description
10 minutes per day of meditation via the Calm app.
Primary Outcome Measure Information:
Title
Burnout
Description
The Maslach Burnout Inventory is a 22-item inventory used to measure aspects of the burnout syndrome within three subscales: emotional exhaustion, depersonalization, and personal accomplishment. Using a seven-point scale (0, never; 1, a few times per year; 2, once a month; 3, a few times a month; 4, once a week; 5, a few times a week; 6, every day), participants rate their experience of burnout. Possible scores on the emotional exhaustion subscale range from 0 to 54. Possible scores on the depersonalization subscale range from 0 to 30. For both the emotional exhaustion and depersonalization subscales, higher mean scores correspond to higher degrees of burnout. Possible scores on the personal accomplishment subscale range from 0 to 48. Lower mean scores on the personal accomplishment subscale correspond to higher degrees of burnout. Scores are computes via sum.
Time Frame
Change from baseline to post-intervention (week 4).
Secondary Outcome Measure Information:
Title
Mindfulness
Description
The Freidburg Mindfulness Inventory is used to measure mindfulness using a 14-item questionnaire covering all aspects of mindfulness. Using a four-point scale, (1, rarely; 2, occasionally; 3, fairly often; 4, almost always), participants are asked to characterize their experience of mindfulness. Higher scores indicate higher levels of mindfulness. Scores are computed via sum.
Time Frame
Change from baseline to post-intervention (week 4).
Title
Stress
Description
The Perceived Stress Scale is a 10-item inventory used for the assessment of perceived stress. The scale measures the degree to which situations are appraised as stressful. The items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate higher levels of stress. Scores are computed via sum.
Time Frame
Change from baseline to post-intervention (week 4).
Title
Depression
Description
The Patient Health Questionnaire-9 is used to measure and diagnose depression using a 9-item self-report measure. Items are rated 4-item scale ranging from 0 (Not at all) to 3 (nearly every day). Higher scores correspond with more severe depressive symptoms. Scores are computed via sum.
Time Frame
Change from baseline to post-intervention (week 4).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physician assistant students currently enrolled in school who do not practice meditation regularly > 18 years of age Able to speak/read/understand English Residing in the U.S. Regular internet access via mobile phone, tablet, etc. Willing to participate in app-based meditation program Burnout, classified as a score greater than or equal to 3 on the non-propriety single item burnout measure. Exclusion Criteria: Physician assistant students who currently (within the last six months) practice meditation Professionals who identify as a practicing physician assistant People who are not currently enrolled in physician assistant school Individuals who are not burnt out, classified as a score less than or equal to 2 on the non-propriety single item burnout measure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Huberty, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Biomedical Collaborative
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Meditation for Burnout in PA Students

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