NCT04169724

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

November 18, 2019

Last Update Submit

April 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mindfulness

    Change from baseline to post-intervention (week 4).

  • Stress

    Change from baseline to post-intervention (week 4).

  • Depression

    Change from baseline to post-intervention (week 4).

Study Arms (2)

Calm

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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.

Interventions

Calm MeditationBEHAVIORAL

10 minutes per day of meditation via the Calm app.

Calm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Jennifer Huberty, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

September 30, 2019

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations