- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613441
Impact of Mindful Awareness Practices in Pediatric Residency Training
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 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.
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Please refer to arm description
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NO_INTERVENTION: Control
Waitlist control (intervention will be available to this group at the end of the study period)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Baseline and at 2 months (immediately post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symptoms of burnout per Abbreviated Maslach Burnout Inventory-9
Time Frame: Baseline and at 2 months (immediately post-intervention)
|
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.
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Baseline and at 2 months (immediately post-intervention)
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Change in symptoms of depression per Beck Depression Inventory (BDI)
Time Frame: Baseline and at 2 months (immediately post-intervention)
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Validated self-report questionnaire of symptoms of depression.
Scores range from 0-63.
Higher scores represent a worse outcome.
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Baseline and at 2 months (immediately post-intervention)
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Change in symptoms of anxiety per Beck Anxiety Inventory (BAI)
Time Frame: Baseline and at 2 months (immediately post-intervention)
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Validated self-report questionnaire of symptoms of anxiety.
Scores range from 0-63.
Higher scores represent a worse outcome.
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Baseline and at 2 months (immediately post-intervention)
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Change in level of loneliness per UCLA Loneliness Scale
Time Frame: Baseline and at 2 months (immediately post-intervention)
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Validated self-report questionnaire of frequency of feeling lonely.
Scores range from 20-80.
Higher scores represent a worse outcome.
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Baseline and at 2 months (immediately post-intervention)
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Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and at 2 months (immediately post-intervention)
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Validated self-report questionnaire evaluated sleep quality.
Scores range from 0-21.
Higher scores represent a worse outcome.
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Baseline and at 2 months (immediately post-intervention)
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Change in level of mindfulness per Mindful Attention Awareness Scale (MAAS)
Time Frame: Baseline and at 2 months (immediately post-intervention)
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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.
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Baseline and at 2 months (immediately post-intervention)
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Collaborators and Investigators
Investigators
- Study Director: Michael Irwin, MD, University of California, Los Angeles
Publications and helpful links
General Publications
- Kunzler 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.
- 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.
- Dyrbye 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.
- Irving 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.
- Romcevich 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.
- Goldhagen 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.
- Purdie 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. 2022 Jul 1. doi: 10.1007/s10880-022-09896-3. Online ahead of print.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-001817
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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