Unwinding Physician Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137081
• Other study ID #: H00014985
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Burnout, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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