Burnout, ProfessionalNCT06003699
Mindfulness Training in the Medical Health Care System
A study testing Search Inside Yourself (SIY) program in people with Burnout, Professional and Stress, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burnout, Professional, Stress, Emotion Regulation
- What is being tested?
- Search Inside Yourself (SIY) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 18 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are between 18 and 80 years of age
- Individuals who are fluent English speakers
- Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
- Individuals who are willing and able to consent to participate in the study
Who cannot join
- 1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
McLaren Health Care Corporation
Grand Blanc, Michigan, 48439
About this study
The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.
- Conditions
- Burnout, Professional, Stress, Emotion Regulation
- Being tested
- Search Inside Yourself (SIY) program
- Medical subject headings
- Burnout, Professional, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search Inside Yourself (SIY) programBehavioural
The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training group | Experimental | Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval. Receives: Behavioral: Search Inside Yourself (SIY) program |
| Wait-list Control Group | Active comparator | Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval. Receives: Behavioral: Search Inside Yourself (SIY) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive Affect
Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Measured: Baseline, up to 11 weeks
Change in Negative Affect
Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Measured: Baseline, up to 11 weeks
Change in Perceived Stress
Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
Measured: Baseline, up to 11 weeks
Change in Decentering
Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
Measured: Baseline, up to 11 weeks
Change in Mindfulness
Mindfulness is assessed with the 15-item short version of the Five Factor Mindfulness Questionnaire (FFMQ). The scores range from 15 to 75 with higher scores indicating greater levels of mindfulness.
Measured: Baseline, up to 11 weeks
Change in Leadership Self-Awareness
Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.
Measured: Baseline, up to 11 weeks
Change in Workplace Emotional Intelligence
Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.
Measured: Baseline, up to 11 weeks
Secondary outcomes (5)
Change in Attentional Performance
The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.
Measured: Baseline, up to 11 weeks
Change in Depression and Anxiety
Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 ("not at all") to 3 ("nearly every day"), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.
Measured: Baseline, up to 11 weeks
Change in Burnout
Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 ("never") to 5 ("always"). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.
Measured: Baseline, up to 11 weeks
Change in Flourishing
Flourishing will be assessed using the 8-item Flourishing Scale. Each item is rated on a 7-point Likert scale from 0 ("Strongly disagree") to 7 ("Strongly agree"). Ratings are then averaged with higher scores representing greater psychological resources and strengths.
Measured: Baseline, up to 11 weeks
Change in Sleep
Sleep problems will be assessed with one question assessing the overall quality of the participants' sleep. The item is rated on a 4-point Likert scale. Scores range from 0 to 3 with a higher score indicating lower quality sleep.
Measured: Baseline, up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Feb 2024
- Primary completion10 Jun 2024
- Study completion18 Jun 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amishi Jha, University of Miami
- Investigators
- Amishi Jha, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003699
- Sponsor's protocol ID
- 20230690
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2023
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training in the Medical Health Care System
- ClinicalTrials.gov ID
- NCT06003699
- Acronym / sponsor ID
- 20230690
- Conditions
- Burnout, Professional, Stress, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 22 Aug 2023 (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 look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training group | Experimental | Behavioral: Search Inside Yourself (SIY) programParticipants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval. |
| Wait-list Control Group | Active comparator | Behavioral: Search Inside Yourself (SIY) programParticipants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who are between 18 and 80 years of age
- Individuals who are fluent English speakers
- Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
- Individuals who are willing and able to consent to participate in the study
Key exclusion criteria (1 listed)
- 1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
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 |
|---|---|---|
| Search Inside Yourself (SIY) programThe present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules. | Behavioural | Mindfulness training group, Wait-list Control Group |
Primary outcome
Change in Positive Affect
Time frame: Baseline, up to 11 weeks
Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Change in Negative Affect
Time frame: Baseline, up to 11 weeks
Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Change in Perceived Stress
Time frame: Baseline, up to 11 weeks
Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
Change in Decentering
Time frame: Baseline, up to 11 weeks
Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
Change in Mindfulness
Time frame: Baseline, up to 11 weeks
Mindfulness is assessed with the 15-item short version of the Five Factor Mindfulness Questionnaire (FFMQ). The scores range from 15 to 75 with higher scores indicating greater levels of mindfulness.
Change in Leadership Self-Awareness
Time frame: Baseline, up to 11 weeks
Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.
Change in Workplace Emotional Intelligence
Time frame: Baseline, up to 11 weeks
Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.
5 secondary outcomes
Change in Attentional Performance
Time frame: Baseline, up to 11 weeks
Change in Depression and Anxiety
Time frame: Baseline, up to 11 weeks
Change in Burnout
Time frame: Baseline, up to 11 weeks
Change in Flourishing
Time frame: Baseline, up to 11 weeks
Change in Sleep
Time frame: Baseline, up to 11 weeks
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 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Burnout, Professional
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Recruiting
A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
Burnout, Healthcare Workers, Breathing Exercises
Recruiting
Professional Readiness Through Emotional Preparedness (PREP)
Burnout
Enrolling by invitationObservational study
Floatation Experience in Nurses and Physicians
Burnout, Professional, Negative Affect
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.
Amishi Jha, 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 Search Inside Yourself (SIY) program 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 4 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 27 Jun 2024. 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 Positive Affect (time frame: Baseline, up to 11 weeks). The study lists 7 primary outcomes in all. 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 27 Jun 2024.