Impact of Mindful Awareness Practices in Pediatric Residency Training

August 1, 2018 updated by: Denise Rita Purdie, MD, FAAP, University of California, Los Angeles
This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Please refer to arm description
NO_INTERVENTION: Control
Waitlist control (intervention will be available to this group at the end of the study period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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)
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)
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.
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)
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)
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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Michael Irwin, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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