Perceived StressNCT04374786
Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic
A study testing Calm Meditation App in people with Perceived Stress and Anxiety, run by University of Arizona at 1 site in United States.
Trial summary
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress, Anxiety, Sleep Disturbance
- What is being tested?
- Calm Meditation App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 1 Dec 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Who cannot join
- Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Read the detailed description
The COVID-19 global pandemic is significantly impacting healthcare providers and presumably affecting their stress level as they deal with this time of uncertainty. The COVID-19 public health crisis requires the full resources and attention of healthcare systems. This has led to several healthcare changes that affect physicians in training, including changes to rotations and schedules, risks of infection exposure to themselves or their families, and the unknown impacts this may have on their residency and fellowship experiences.
These changes are likely impacting their stress, health, and well-being. Physician burnout is major concern for the medical community and likely to be further impacted by the current pandemic. Evidence-based interventions for stress include cognitive behavior therapy, although this can be time consuming, requires the need for specialized providers, and is not feasible for everyone during this COVID-19 pandemic. Pharmacotherapy can be used, including antidepressants and anxiolytics, however they have inherent limitations such as side effects, tolerance, and interactions that limit their use. Consumer based mobile applications (apps) may help individuals with self-management strategies for stress. Mindfulness meditation is one type of self-management strategy and is the practice of moment-to-moment awareness in which the person purposefully focuses on the present without judgement.
"Calm" is a mobile app that offers a range of meditation lessons, sleep stories (bed-time stories for grown-ups), sleep music, and nature sounds with modules that vary in length, instruction, and content. Few studies on the use of "Calm" exist and include a randomized controlled trial evaluating its affect to decrease stress among college students and a descriptive study evaluating cancer patient's perceptions of the app. There is evidence to support the use of similar apps in resident physicians. A pilot study assessing the effects of a meditation app on resident wellness suggested both the feasibility and efficacy of such an intervention. During these unprecedented times of the COVID-19 pandemic, mobile apps such as Calm may be potentially beneficial to help with stress in house staff physicians, although this requires further investigation.
- Conditions
- Perceived Stress, Anxiety, Sleep Disturbance, Burnout, PTSD
- Being tested
- Calm Meditation App
- Keywords
- COVID-19, mindfulness meditation
- Medical subject headings
- Anxiety Disorders, Parasomnias, Burnout, Psychological, Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Meditation AppDevice
Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Will receive a 30-day are trial of the mobile meditation app "Calm" on study day 0 Receives: Device: Calm Meditation App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Completed study Day 0
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Completed study Day 14
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Completed study Day 30
Secondary outcomes (7)
Hospital Anxiety and Depression Scale
Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Measured: Completed study Day 0, 14, and study Day 30
PROMIS Sleep Disturbance Short Form Survey
Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Measured: Completed study Day 0, 14, and study Day 30
Impact of Event Scale-6
The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.
Measured: Completed study Day 0, 14, and study Day 30
Maslach Burnout Inventory
The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.
Measured: Completed study Day 0, 14, and study Day 30
Adherence
Usage data from mobile app, minutes per day used
Measured: From Day 0 to Day 30
Coronavirus Questionnaire
Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.
Measured: Completed study Day 0 and study Day 30
Participant Satisfaction
Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.
Measured: Completed study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start15 May 2020
- Primary completion15 Jul 2020
- Study completion1 Dec 2020
Why it stopped: Loss to follow up. No longer enrolling.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelley Saunders, University of Arizona
- Investigators
- Mike Foley, MD, Study chair, Chair - BUMCP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374786
- Sponsor's protocol ID
- 2003524869 [Sub-study]
- Status last verified
- Nov 2025
- First submitted
- 1 May 2020
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
PubMed 31237569Huberty J, Vranceanu AM, Carney C, Breus M, Gordon M, Puzia ME. Characteristics and Usage Patterns Among 12,151 Paid Subscribers of the Calm Meditation App: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2019 Nov 3;7(11):e15648. doi: 10.2196/15648.
PubMed 31682582Huberty J, Puzia M, Eckert R, Larkey L. Cancer Patients' and Survivors' Perceptions of the Calm App: Cross-Sectional Descriptive Study. JMIR Cancer. 2020 Jan 25;6(1):e16926. doi: 10.2196/16926.
PubMed 32039812Wen L, Sweeney TE, Welton L, Trockel M, Katznelson L. Encouraging Mindfulness in Medical House Staff via Smartphone App: A Pilot Study. Acad Psychiatry. 2017 Oct;41(5):646-650. doi: 10.1007/s40596-017-0768-3. Epub 2017 Aug 9.
PubMed 28795335
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
- ClinicalTrials.gov ID
- NCT04374786
- Acronym / sponsor ID
- 2003524869 [Sub-study]
- Conditions
- Perceived Stress, Anxiety, Sleep Disturbance, Burnout, PTSD
- Keywords
- COVID-19, mindfulness meditation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss to follow up. No longer enrolling.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 May 2020 (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.
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Detailed description
The COVID-19 global pandemic is significantly impacting healthcare providers and presumably affecting their stress level as they deal with this time of uncertainty. The COVID-19 public health crisis requires the full resources and attention of healthcare systems. This has led to several healthcare changes that affect physicians in training, including changes to rotations and schedules, risks of infection exposure to themselves or their families, and the unknown impacts this may have on their residency and fellowship experiences.
These changes are likely impacting their stress, health, and well-being. Physician burnout is major concern for the medical community and likely to be further impacted by the current pandemic. Evidence-based interventions for stress include cognitive behavior therapy, although this can be time consuming, requires the need for specialized providers, and is not feasible for everyone during this COVID-19 pandemic. Pharmacotherapy can be used, including antidepressants and anxiolytics, however they have inherent limitations such as side effects, tolerance, and interactions that limit their use. Consumer based mobile applications (apps) may help individuals with self-management strategies for stress. Mindfulness meditation is one type of self-management strategy and is the practice of moment-to-moment awareness in which the person purposefully focuses on the present without judgement.
"Calm" is a mobile app that offers a range of meditation lessons, sleep stories (bed-time stories for grown-ups), sleep music, and nature sounds with modules that vary in length, instruction, and content. Few studies on the use of "Calm" exist and include a randomized controlled trial evaluating its affect to decrease stress among college students and a descriptive study evaluating cancer patient's perceptions of the app. There is evidence to support the use of similar apps in resident physicians. A pilot study assessing the effects of a meditation app on resident wellness suggested both the feasibility and efficacy of such an intervention. During these unprecedented times of the COVID-19 pandemic, mobile apps such as Calm may be potentially beneficial to help with stress in house staff physicians, although this requires further investigation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Calm Meditation AppWill receive a 30-day are trial of the mobile meditation app "Calm" on study day 0 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Key exclusion criteria (1 listed)
- Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
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 Meditation AppMeditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. | Device | Intervention Group |
Primary outcome
Perceived Stress Scale
Time frame: Completed study Day 0
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Perceived Stress Scale
Time frame: Completed study Day 14
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Perceived Stress Scale
Time frame: Completed study Day 30
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
7 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Completed study Day 0, 14, and study Day 30
PROMIS Sleep Disturbance Short Form Survey
Time frame: Completed study Day 0, 14, and study Day 30
Impact of Event Scale-6
Time frame: Completed study Day 0, 14, and study Day 30
Maslach Burnout Inventory
Time frame: Completed study Day 0, 14, and study Day 30
Adherence
Time frame: From Day 0 to Day 30
Coronavirus Questionnaire
Time frame: Completed study Day 0 and study Day 30
Participant Satisfaction
Time frame: Completed study Day 30
Results and safety
The study was stopped early (reason given: Loss to follow up. No longer enrolling.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Results publication: PubMed 31237569Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
- Results publication: PubMed 31682582Huberty J, Vranceanu AM, Carney C, Breus M, Gordon M, Puzia ME. Characteristics and Usage Patterns Among 12,151 Paid Subscribers of the Calm Meditation App: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2019 Nov 3;7(11):e15648. doi: 10.2196/15648.
- Results publication: PubMed 32039812Huberty J, Puzia M, Eckert R, Larkey L. Cancer Patients' and Survivors' Perceptions of the Calm App: Cross-Sectional Descriptive Study. JMIR Cancer. 2020 Jan 25;6(1):e16926. doi: 10.2196/16926.
- Results publication: PubMed 28795335Wen L, Sweeney TE, Welton L, Trockel M, Katznelson L. Encouraging Mindfulness in Medical House Staff via Smartphone App: A Pilot Study. Acad Psychiatry. 2017 Oct;41(5):646-650. doi: 10.1007/s40596-017-0768-3. Epub 2017 Aug 9.
- 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.
Mike Foley, MD study chair
Chair - BUMCP
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 App in people with Perceived Stress and Anxiety, run by University of Arizona 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Nov 2025. 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 was stopped early (reason given: Loss to follow up. No longer enrolling.). Results are not available in the source record.
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?
Perceived Stress Scale (time frame: Completed study Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04374786, which also lists 4 linked publications.
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 10 Nov 2025.