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Impact of Mindful Awareness Practices in Pediatric Residency Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613441
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Denise Rita Purdie, MD, FAAP, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Stress Burnout, Professional Behavioral: Mindful Awareness Practices (MAPs) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Mindful Awareness Practices in Pediatric Residency Training
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
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.
Behavioral: Mindful Awareness Practices (MAPs)
Please refer to arm description

No Intervention: Control
Waitlist control (intervention will be available to this group at the end of the study period)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in symptoms of depression per Beck Depression Inventory (BDI) [ Time Frame: Baseline and at 2 months (immediately post-intervention) ]
    Validated self-report questionnaire of symptoms of depression. Scores range from 0-63. Higher scores represent a worse outcome.

  3. Change in symptoms of anxiety per Beck Anxiety Inventory (BAI) [ Time Frame: Baseline and at 2 months (immediately post-intervention) ]
    Validated self-report questionnaire of symptoms of anxiety. Scores range from 0-63. Higher scores represent a worse outcome.

  4. Change in level of loneliness per UCLA Loneliness Scale [ Time Frame: Baseline and at 2 months (immediately post-intervention) ]
    Validated self-report questionnaire of frequency of feeling lonely. Scores range from 20-80. Higher scores represent a worse outcome.

  5. Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and at 2 months (immediately post-intervention) ]
    Validated self-report questionnaire evaluated sleep quality. Scores range from 0-21. Higher scores represent a worse outcome.

  6. Change in level of mindfulness per Mindful Attention Awareness Scale (MAAS) [ Time Frame: Baseline and at 2 months (immediately post-intervention) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613441


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Study Director: Michael Irwin, MD University of California, Los Angeles

Publications:
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Responsible Party: Denise Rita Purdie, MD, FAAP, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03613441    
Other Study ID Numbers: 16-001817
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denise Rita Purdie, MD, FAAP, University of California, Los Angeles:
Mindfulness
Residency training
Additional relevant MeSH terms:
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Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases