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OpenTrials
Completed

NCT Number: NCT04137081

Unwinding Physician Anxiety

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently employed as a physician
  • Direct patient interaction
  • Owns a smartphone
  • Endorsed anxiety based on answering yes to following questions:
  • Do you feel nervous, anxious, or on edge?
  • 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

Treatment and study plan

App-based Mindfulness Training

Behavioral

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.

Primary outcomes

  1. Changes in anxiety

    Time frame: 1 month

    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.

Secondary outcomes

  1. Changes in burnout

    Time frame: 1 month

    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.

  2. Program engagement

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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