AnxietyNCT04137081
Unwinding Physician Anxiety
A study testing App-based mindfulness training in people with Anxiety and Burnout, Professional, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Burnout, Professional
- What is being tested?
- App-based mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Managing Risk at Its Source: Reducing Clinician Burnout Through Digital Therapeutic Delivery of Mindfulness Training
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.
Read the 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.
- Conditions
- Anxiety, Burnout, Professional
- Being tested
- App-based mindfulness training
- Keywords
- Physicians
- Medical subject headings
- Anxiety Disorders, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based mindfulness trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-based mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start3 Apr 2018
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judson Brewer, University of Massachusetts, Worcester
- Investigators
- Principal Investigator, Principal investigator, UMass Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137081
- Sponsor's protocol ID
- H00014985
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32234708
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Risk at Its Source: Reducing Clinician Burnout Through Digital Therapeutic Delivery of Mindfulness Training
- ClinicalTrials.gov ID
- NCT04137081
- Acronym / sponsor ID
- H00014985
- Conditions
- Anxiety, Burnout, Professional
- Keywords
- Physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App-based mindfulness training | Experimental | Behavioral: App-based mindfulness trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently employed as a physician
- Direct patient interaction
- Owns a smartphone
- Endorsed anxiety based on answering yes to following questions:
- Endorsed willingness to use smartphone app for 10+ minutes/day for 30 days
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based mindfulness trainingUnwinding 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. | Behavioural | App-based mindfulness training |
Primary outcome
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.
2 secondary outcomes
Changes in burnout
Time frame: 1 month
Program engagement
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Derived from this study: PubMed 32234708Roy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator principal investigator
UMass Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based mindfulness training in people with Anxiety and Burnout, Professional, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anxiety (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.