Unwinding Physician Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anxiety, Burnout, Professional

Intervention / Treatment
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* Behavioral: App-based mindfulness training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-based mindfulness training<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physicians