Impact of Mindful Awareness Practices in Pediatric Residency Training

Stress Clinical Trial

Official title:

Impact of Mindful Awareness Practices in Pediatric Residency Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613441
• Other study ID #: 16-001817
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Burnout, Professional
• Stress

Intervention

Behavioral:
• Mindful Awareness Practices (MAPs)
Please refer to arm description

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)
Secondary	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.	Baseline and at 2 months (immediately post-intervention)