StressNCT03613441
Impact of Mindful Awareness Practices in Pediatric Residency Training
A study testing Mindful Awareness Practices (MAPs) in people with Stress and Burnout, Professional, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional
- What is being tested?
- Mindful Awareness Practices (MAPs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Apr 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
- Pediatric resident at the University of California Los Angeles's Mattel Children's Hospital
- Medicine/Pediatric resident at University of California Los Angeles's Mattel Children's Hospital
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.
Read the detailed description
Recent research studies have indicated that the practice of mindfulness is strongly correlated with enhanced well-being and improved resilience in a variety of populations. Mindfulness-based interventions have been shown to reduce stress and symptoms of burnout in physicians. However, the two studies that included residents were observational trials evaluating the effect of an abbreviated, informal mindfulness course.
The aim of the investigator's study is to assess whether a standardized course in mindfulness meditation (Mindful Awareness Practices, MAPs) reduces self--reported signs and symptoms of stress, burnout, depression, anxiety, loneliness and poor sleep quality in residents in pediatrics training. This study is a randomized controlled trial using 2 parallel groups. The pediatrics residents randomized to the intervention will participate in a standardized mindful awareness practices intervention consisting of one live 45- minute session and 5 web--based self--study sessions. The live session will be administered by a trained mindfulness educator at the UCLA Westwood, Olive View Medical Center and Cedars--Sinai Medical Center campuses. The waitlist group will have the opportunity to participate in the same course once the study has been completed. Participants will respond to questionnaires to assess for levels of stress and other mental health measures before and after the intervention to see if the intervention group had a reduction in symptoms compared to the waitlist group.
- Conditions
- Stress, Burnout, Professional
- Being tested
- Mindful Awareness Practices (MAPs)
- Keywords
- Mindfulness, Residency training
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness Practices (MAPs)Behavioural
Please refer to arm description
| Study group | Role | What they receive |
|---|---|---|
| Mindful Awareness Practices (MAPs) | Experimental | Mindful Awareness Practices is a mindfulness-based intervention developed at UCLA's Mindful Awareness Research Center. It is a weekly 2-hour, 6-session, group-based course in mindfulness meditation that is available in-person or online. Receives: Behavioral: Mindful Awareness Practices (MAPs) |
| Control | No intervention | Waitlist control (intervention will be available to this group at the end of the study period) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of stress per Perceived Stress Scale (PSS)
PSS = validated 14-item self-report questionnaire of stress experienced over past month. Scores range from 0-56. Higher scores represent a worse outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Secondary outcomes (6)
Change in symptoms of burnout per Abbreviated Maslach Burnout Inventory-9
Physician-specific self-report questionnaire of symptoms of burnout. The inventory is divided into three subscales: emotional exhaustion, depersonalization and personal accomplishment. Each subscale scores from 0-18. The subscales are reported separately rather than added together for a total score. Higher scores represent a worse outcome, except on the personal accomplishment subscale, where higher scores represent better outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Change in symptoms of depression per Beck Depression Inventory (BDI)
Validated self-report questionnaire of symptoms of depression. Scores range from 0-63. Higher scores represent a worse outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Change in symptoms of anxiety per Beck Anxiety Inventory (BAI)
Validated self-report questionnaire of symptoms of anxiety. Scores range from 0-63. Higher scores represent a worse outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Change in level of loneliness per UCLA Loneliness Scale
Validated self-report questionnaire of frequency of feeling lonely. Scores range from 20-80. Higher scores represent a worse outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI)
Validated self-report questionnaire evaluated sleep quality. Scores range from 0-21. Higher scores represent a worse outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Change in level of mindfulness per Mindful Attention Awareness Scale (MAAS)
MAAS = validated 15-item self-report questionnaire of tendency to be attentive to and aware of experiences in daily life. Scores range from 15-90. Higher scores represent a better outcome.
Measured: Baseline and at 2 months (immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jun 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Rita Purdie, MD, FAAP, University of California, Los Angeles
- Investigators
- Michael Irwin, MD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613441
- Sponsor's protocol ID
- 16-001817
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dyrbye L, Shanafelt T. A narrative review on burnout experienced by medical students and residents. Med Educ. 2016 Jan;50(1):132-49. doi: 10.1111/medu.12927.
PubMed 26695473Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.
PubMed 24448053Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.
PubMed 19341981Romcevich LE, Reed S, Flowers SR, Kemper KJ, Mahan JD. Mind-Body Skills Training for Resident Wellness: A Pilot Study of a Brief Mindfulness Intervention. J Med Educ Curric Dev. 2018 Apr 30;5:2382120518773061. doi: 10.1177/2382120518773061. eCollection 2018 Jan-Dec.
PubMed 29780891Goldhagen BE, Kingsolver K, Stinnett SS, Rosdahl JA. Stress and burnout in residents: impact of mindfulness-based resilience training. Adv Med Educ Pract. 2015 Aug 25;6:525-32. doi: 10.2147/AMEP.S88580. eCollection 2015.
PubMed 26347361Purdie DR, Federman M, Chin A, Winston D, Bursch B, Olmstead R, Bulut Y, Irwin MR. Hybrid Delivery of Mindfulness Meditation and Perceived Stress in Pediatric Resident Physicians: A Randomized Clinical Trial of In-Person and Digital Mindfulness Meditation. J Clin Psychol Med Settings. 2023 Jun;30(2):425-434. doi: 10.1007/s10880-022-09896-3. Epub 2022 Jul 1.
PubMed 35778655Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
PubMed 32627860
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindful Awareness Practices in Pediatric Residency Training
- ClinicalTrials.gov ID
- NCT03613441
- Acronym / sponsor ID
- 16-001817
- Conditions
- Stress, Burnout, Professional
- Keywords
- Mindfulness, Residency training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Aug 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.
This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.
Detailed description
Recent research studies have indicated that the practice of mindfulness is strongly correlated with enhanced well-being and improved resilience in a variety of populations. Mindfulness-based interventions have been shown to reduce stress and symptoms of burnout in physicians. However, the two studies that included residents were observational trials evaluating the effect of an abbreviated, informal mindfulness course.
The aim of the investigator's study is to assess whether a standardized course in mindfulness meditation (Mindful Awareness Practices, MAPs) reduces self--reported signs and symptoms of stress, burnout, depression, anxiety, loneliness and poor sleep quality in residents in pediatrics training. This study is a randomized controlled trial using 2 parallel groups. The pediatrics residents randomized to the intervention will participate in a standardized mindful awareness practices intervention consisting of one live 45- minute session and 5 web--based self--study sessions. The live session will be administered by a trained mindfulness educator at the UCLA Westwood, Olive View Medical Center and Cedars--Sinai Medical Center campuses. The waitlist group will have the opportunity to participate in the same course once the study has been completed. Participants will respond to questionnaires to assess for levels of stress and other mental health measures before and after the intervention to see if the intervention group had a reduction in symptoms compared to the waitlist group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Awareness Practices (MAPs) | Experimental | Behavioral: Mindful Awareness Practices (MAPs)Mindful Awareness Practices is a mindfulness-based intervention developed at UCLA's Mindful Awareness Research Center. It is a weekly 2-hour, 6-session, group-based course in mindfulness meditation that is available in-person or online. |
| Control | No intervention | –Waitlist control (intervention will be available to this group at the end of the study period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pediatric resident at the University of California Los Angeles's Mattel Children's Hospital
- Medicine/Pediatric resident at University of California Los Angeles's Mattel Children's Hospital
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 |
|---|---|---|
| Mindful Awareness Practices (MAPs)Please refer to arm description | Behavioural | Mindful Awareness Practices (MAPs) |
Primary outcome
Change in level of stress per Perceived Stress Scale (PSS)
Time frame: Baseline and at 2 months (immediately post-intervention)
PSS = validated 14-item self-report questionnaire of stress experienced over past month. Scores range from 0-56. Higher scores represent a worse outcome.
6 secondary outcomes
Change in symptoms of burnout per Abbreviated Maslach Burnout Inventory-9
Time frame: Baseline and at 2 months (immediately post-intervention)
Change in symptoms of depression per Beck Depression Inventory (BDI)
Time frame: Baseline and at 2 months (immediately post-intervention)
Change in symptoms of anxiety per Beck Anxiety Inventory (BAI)
Time frame: Baseline and at 2 months (immediately post-intervention)
Change in level of loneliness per UCLA Loneliness Scale
Time frame: Baseline and at 2 months (immediately post-intervention)
Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and at 2 months (immediately post-intervention)
Change in level of mindfulness per Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline and at 2 months (immediately post-intervention)
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 3 Aug 2018.
- Background: PubMed 26695473Dyrbye L, Shanafelt T. A narrative review on burnout experienced by medical students and residents. Med Educ. 2016 Jan;50(1):132-49. doi: 10.1111/medu.12927.
- Background: PubMed 24448053Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.
- Background: PubMed 19341981Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.
- Background: PubMed 29780891Romcevich LE, Reed S, Flowers SR, Kemper KJ, Mahan JD. Mind-Body Skills Training for Resident Wellness: A Pilot Study of a Brief Mindfulness Intervention. J Med Educ Curric Dev. 2018 Apr 30;5:2382120518773061. doi: 10.1177/2382120518773061. eCollection 2018 Jan-Dec.
- Background: PubMed 26347361Goldhagen BE, Kingsolver K, Stinnett SS, Rosdahl JA. Stress and burnout in residents: impact of mindfulness-based resilience training. Adv Med Educ Pract. 2015 Aug 25;6:525-32. doi: 10.2147/AMEP.S88580. eCollection 2015.
- Derived from this study: PubMed 35778655Purdie DR, Federman M, Chin A, Winston D, Bursch B, Olmstead R, Bulut Y, Irwin MR. Hybrid Delivery of Mindfulness Meditation and Perceived Stress in Pediatric Resident Physicians: A Randomized Clinical Trial of In-Person and Digital Mindfulness Meditation. J Clin Psychol Med Settings. 2023 Jun;30(2):425-434. doi: 10.1007/s10880-022-09896-3. Epub 2022 Jul 1.
- Derived from this study: PubMed 32627860Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Michael Irwin, MD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness Practices (MAPs) in people with Stress and Burnout, Professional, run by University of California, Los Angeles 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 2 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 3 Aug 2018. 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 level of stress per Perceived Stress Scale (PSS) (time frame: Baseline and at 2 months (immediately post-intervention)). 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 NCT03613441, which also lists 7 linked publications.
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 3 Aug 2018.