Impact of Mindful Awareness Practices in Pediatric Residency Training
Primary Purpose
Stress, Burnout, Professional
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Awareness Practices (MAPs)
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Mindfulness, Residency training
Eligibility Criteria
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
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindful Awareness Practices (MAPs)
Control
Arm Description
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.
Waitlist control (intervention will be available to this group at the end of the study period)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03613441
First Posted
July 19, 2018
Last Updated
August 1, 2018
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03613441
Brief Title
Impact of Mindful Awareness Practices in Pediatric Residency Training
Official Title
Impact of Mindful Awareness Practices in Pediatric Residency Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout, Professional
Keywords
Mindfulness, Residency training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindful Awareness Practices (MAPs)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waitlist control (intervention will be available to this group at the end of the study period)
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness Practices (MAPs)
Intervention Description
Please refer to arm description
Primary Outcome Measure Information:
Title
Change in level of stress per Perceived Stress Scale (PSS)
Description
PSS = validated 14-item self-report questionnaire of stress experienced over past month. Scores range from 0-56. Higher scores represent a worse outcome.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Secondary Outcome Measure Information:
Title
Change in symptoms of burnout per Abbreviated Maslach Burnout Inventory-9
Description
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.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Title
Change in symptoms of depression per Beck Depression Inventory (BDI)
Description
Validated self-report questionnaire of symptoms of depression. Scores range from 0-63. Higher scores represent a worse outcome.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Title
Change in symptoms of anxiety per Beck Anxiety Inventory (BAI)
Description
Validated self-report questionnaire of symptoms of anxiety. Scores range from 0-63. Higher scores represent a worse outcome.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Title
Change in level of loneliness per UCLA Loneliness Scale
Description
Validated self-report questionnaire of frequency of feeling lonely. Scores range from 20-80. Higher scores represent a worse outcome.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Title
Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI)
Description
Validated self-report questionnaire evaluated sleep quality. Scores range from 0-21. Higher scores represent a worse outcome.
Time Frame
Baseline and at 2 months (immediately post-intervention)
Title
Change in level of mindfulness per Mindful Attention Awareness Scale (MAAS)
Description
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.
Time Frame
Baseline and at 2 months (immediately post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Irwin, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26695473
Citation
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.
Results Reference
background
PubMed Identifier
24448053
Citation
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.
Results Reference
background
PubMed Identifier
19341981
Citation
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.
Results Reference
background
PubMed Identifier
29780891
Citation
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.
Results Reference
background
PubMed Identifier
26347361
Citation
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.
Results Reference
background
PubMed Identifier
35778655
Citation
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. 2023 Jun;30(2):425-434. doi: 10.1007/s10880-022-09896-3. Epub 2022 Jul 1.
Results Reference
derived
PubMed Identifier
32627860
Citation
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.
Results Reference
derived
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Impact of Mindful Awareness Practices in Pediatric Residency Training
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