Meditation for Burnout in PA Students

Feasibility of The Mindfulness Meditation App "Calm" to Reduce Burnout in Physician Assistant Students

This study investigates the feasibility and effects of an app-based mindfulness meditation intervention for PA students.

Study Overview

• Status: Completed
• Conditions: Burnout, Student; Feasibility
• Intervention / Treatment: Behavioral: Calm Meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Biomedical Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calm; 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.	Behavioral: Calm Meditation; 10 minutes per day of meditation via the Calm app.
No Intervention: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to post-intervention (week 4).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to post-intervention (week 4).
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.	Change from baseline to post-intervention (week 4).
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.	Change from baseline to post-intervention (week 4).

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Calm.com, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: STUDY00010572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No