Burnout, ProfessionalNCT03514862
Mindfulness Training for Medical Personnel
A study testing Mindfulness Booster Training, Mindfulness-Based Intervention (MBI) and Self-Practice in people with Burnout, Professional and Stress, run by University of Miami at 1 site in United States.
Trial summary
In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress
- What is being tested?
- Mindfulness Booster Training, Mindfulness-Based Intervention (MBI) and Self-Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 27 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.
Who cannot join
- Those not falling into inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.
- Conditions
- Burnout, Professional, Stress
- Being tested
- Mindfulness Booster Training, Mindfulness-Based Intervention (MBI), Self-Practice
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Booster TrainingBehavioural
Four additional mindfulness booster sessions after the 4-week MBI program.
Mindfulness-Based Intervention (MBI)Behavioural
MBI program is delivered once a week for 4 weeks, 90 minutes each preceded by a 90-minute orientation session. The training sessions will include discussion, and introduction and practice of mindfulness practices.
Self-PracticeBehavioural
4 weeks of self-practice after the MBI training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then will be invited to continue to participate in 4 additional Mindfulness Booster Training. Receives: Behavioral: Mindfulness Booster Training; Behavioral: Mindfulness-Based Intervention (MBI) |
| Control | Active comparator | Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks. Receives: Behavioral: Mindfulness Booster Training; Behavioral: Self-Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measure of stress
Stress will be measured using the Perceived Stress Scale, a short-form 4 item scale with a range of 0 to 16, with higher scores representing greater stress. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Measured: Baseline, 4-weeks, 3-months, 6-months
Secondary outcomes (1)
Change in measure of burnout
Burnout is measured using the 19-item Copenhagen Burnout Inventory including subscales assessing personal burnout, work-related burnout and patient-related burnout. Scores range from 0 to 100. Total score on the scale is the average of the scores on the items with a higher mean representing greater burnout. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Measured: Baseline, 4-weeks, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start29 Mar 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Lee, PhD, University of Miami
- Investigators
- David J Lee, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514862
- Sponsor's protocol ID
- 20180138
- Status last verified
- Feb 2019
- First submitted
- 20 Apr 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
- ClinicalTrials.gov ID
- NCT03514862
- Acronym / sponsor ID
- 20180138
- Conditions
- Burnout, Professional, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 2 May 2018 (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.
In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness Booster Training, Behavioral: Mindfulness-Based Intervention (MBI)Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then will be invited to continue to participate in 4 additional Mindfulness Booster Training. |
| Control | Active comparator | Behavioral: Mindfulness Booster Training, Behavioral: Self-PracticeParticipants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.
Key exclusion criteria (1 listed)
- Those not falling into inclusion criteria.
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 |
|---|---|---|
| Mindfulness Booster TrainingFour additional mindfulness booster sessions after the 4-week MBI program. | Behavioural | Control, Intervention |
| Mindfulness-Based Intervention (MBI)MBI program is delivered once a week for 4 weeks, 90 minutes each preceded by a 90-minute orientation session. The training sessions will include discussion, and introduction and practice of mindfulness practices. | Behavioural | Intervention |
| Self-Practice4 weeks of self-practice after the MBI training. | Behavioural | Control |
Primary outcome
Change in measure of stress
Time frame: Baseline, 4-weeks, 3-months, 6-months
Stress will be measured using the Perceived Stress Scale, a short-form 4 item scale with a range of 0 to 16, with higher scores representing greater stress. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
1 secondary outcome
Change in measure of burnout
Time frame: Baseline, 4-weeks, 3-months, 6-months
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 12 Feb 2019.
- 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.
David J Lee, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Booster Training, Mindfulness-Based Intervention (MBI) and Self-Practice in people with Burnout, Professional and Stress, run by University of Miami 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 1 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 12 Feb 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?
Change in measure of stress (time frame: Baseline, 4-weeks, 3-months, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2019.