NCT04374786

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

May 1, 2020

Last Update Submit

November 6, 2025

Conditions

Keywords

COVID-19mindfulness meditation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Completed study Day 30

Secondary Outcomes (7)

  • Hospital Anxiety and Depression Scale

    Completed study Day 0, 14, and study Day 30

  • PROMIS Sleep Disturbance Short Form Survey

    Completed study Day 0, 14, and study Day 30

  • Impact of Event Scale-6

    Completed study Day 0, 14, and study Day 30

  • Maslach Burnout Inventory

    Completed study Day 0, 14, and study Day 30

  • Adherence

    From Day 0 to Day 30

  • +2 more secondary outcomes

Study Arms (1)

Intervention Group

EXPERIMENTAL

Will receive a 30-day are trial of the mobile meditation app "Calm" on study day 0

Device: Calm Meditation App

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.

You may not qualify if:

  • Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (4)

  • 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.

  • Huberty 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.

  • Huberty 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.

  • Wen 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.

MeSH Terms

Conditions

Anxiety DisordersParasomniasBurnout, PsychologicalStress Disorders, Post-TraumaticCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersSleep Wake DisordersNervous System DiseasesStress, PsychologicalBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mike Foley, MD

    Chair - BUMCP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

May 15, 2020

Primary Completion

July 15, 2020

Study Completion

December 1, 2020

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations