Unwinding Physician Anxiety

Managing Risk at Its Source: Reducing Clinician Burnout Through Digital Therapeutic Delivery of Mindfulness Training

The purpose of this study is to test an app-based mindfulness training program to see if it can reduce anxiety and burnout in physicians.

Study Overview

• Status: Completed
• Conditions: Burnout, Professional; Anxiety
• Intervention / Treatment: Behavioral: App-based mindfulness training

Detailed Description

In this study, 50 clinicians will be provided access to the Unwinding Anxiety program. The intervention period will last 3 months and changes in anxiety and burnout along with program engagement will be assessed at baseline, 1 month, and 3 months.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

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:

• Currently employed as a physician
• Direct patient interaction
• Owns a smartphone

• Endorsed anxiety based on answering yes to following questions:

  1. Do you feel nervous, anxious, or on edge?
  2. Do you feel you worry too much about different things?
• Endorsed willingness to use smartphone app for 10+ minutes/day for 30 days
• Endorsed willingness to complete online surveys

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: App-based mindfulness training; The Unwinding Anxiety program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.

Behavioral: App-based mindfulness training; Unwinding Anxiety is an app-based mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety	Generalized Anxiety Disorder 7-item (GAD-7) questionnaire will be used to assess anxiety. The GAD-7 uses a 4-point Likert scale where 0 is "Not at all" to 3 "Nearly every day". Scores can range from 0 to 21 and higher scores indicate increasing severity of anxiety.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in burnout	Two, single-item questions from the emotional exhaustion and cynicism domains of the Maslach Burnout Inventory will be used to assess burnout. Both questions are on a 7-point Likert scale where 0 is "never" and 7 is "every day". Scores can range from 0 to 7 for each domain and higher scores indicate increasing levels of burnout.	1 month
Program engagement	Program engagement will be assessed based on the number of modules completed. The program has 30 modules therefore scores scan range from 0 to 30 modules.	1 month

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Principal Investigator, UMass Worcester

Publications and helpful links

General Publications

• Roy A, Druker S, Hoge EA, Brewer JA. Physician Anxiety and Burnout: Symptom Correlates and a Prospective Pilot Study of App-Delivered Mindfulness Training. JMIR Mhealth Uhealth. 2020 Apr 1;8(4):e15608. doi: 10.2196/15608.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Physicians
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Professional; Burnout, Psychological
• Other Study ID Numbers: H00014985

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