NCT04137081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 22, 2019

Last Update Submit

October 22, 2019

Conditions

Keywords

Physicians

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in burnout

    1 month

  • Program engagement

    1 month

Study Arms (1)

App-based mindfulness training

EXPERIMENTAL

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

Interventions

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.

App-based mindfulness training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety DisordersBurnout, Professional

Condition Hierarchy (Ancestors)

Mental DisordersOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Principal Investigator

    UMass Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 23, 2019

Study Start

April 3, 2018

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations