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Unwinding Physician Anxiety

Primary Purpose

Anxiety, Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-based mindfulness training
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Physicians

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App-based mindfulness training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 22, 2019
Last Updated
October 22, 2019
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT04137081
Brief Title
Unwinding Physician Anxiety
Official Title
Managing Risk at Its Source: Reducing Clinician Burnout Through Digital Therapeutic Delivery of Mindfulness Training
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Burnout, Professional
Keywords
Physicians

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App-based mindfulness training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
App-based mindfulness training
Intervention Description
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 Outcome Measure Information:
Title
Changes in anxiety
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in burnout
Description
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.
Time Frame
1 month
Title
Program engagement
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Organizational Affiliation
UMass Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32234708
Citation
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.
Results Reference
derived

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Unwinding Physician Anxiety

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