Burnout, StudentNCT04169724
Meditation for Burnout in PA Students
A study testing Calm Meditation in people with Burnout, Student and Feasibility, run by Arizona State University at 1 site in United States.
Trial summary
This study investigates the feasibility and effects of an app-based mindfulness meditation intervention for PA students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Student, Feasibility
- What is being tested?
- Calm Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout, Student, Feasibility
- Being tested
- Calm Meditation
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm MeditationBehavioural
10 minutes per day of meditation via the Calm app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to post-intervention (week 4).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-intervention (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start30 Sep 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, StudentStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Calm.com, Inc.
- Responsible party
- Sponsor
- Investigators
- Jennifer Huberty, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169724
- Sponsor's protocol ID
- STUDY00010572
- Status last verified
- Apr 2020
- First submitted
- 18 Nov 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of The Mindfulness Meditation App "Calm" to Reduce Burnout in Physician Assistant Students
- ClinicalTrials.gov ID
- NCT04169724
- Acronym / sponsor ID
- STUDY00010572
- Conditions
- Burnout, Student, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Calm.com, Inc.
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm | Experimental | Behavioral: Calm MeditationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm Meditation10 minutes per day of meditation via the Calm app. | Behavioural | Calm |
Primary outcome
Burnout
Time frame: Change from baseline to post-intervention (week 4).
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.
3 secondary outcomes
Mindfulness
Time frame: Change from baseline to post-intervention (week 4).
Stress
Time frame: Change from baseline to post-intervention (week 4).
Depression
Time frame: Change from baseline to post-intervention (week 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Huberty, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Meditation in people with Burnout, Student and Feasibility, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (time frame: Change from baseline to post-intervention (week 4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.