NCT03613441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 19, 2018

Last Update Submit

August 1, 2018

Conditions

Keywords

MindfulnessResidency training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in symptoms of burnout per Abbreviated Maslach Burnout Inventory-9

    Baseline and at 2 months (immediately post-intervention)

  • Change in symptoms of depression per Beck Depression Inventory (BDI)

    Baseline and at 2 months (immediately post-intervention)

  • Change in symptoms of anxiety per Beck Anxiety Inventory (BAI)

    Baseline and at 2 months (immediately post-intervention)

  • Change in level of loneliness per UCLA Loneliness Scale

    Baseline and at 2 months (immediately post-intervention)

  • Change in level of sleep quality per Pittsburgh Sleep Quality Index (PSQI)

    Baseline and at 2 months (immediately post-intervention)

  • +1 more secondary outcomes

Study Arms (2)

Mindful Awareness Practices (MAPs)

EXPERIMENTAL

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)

Control

NO INTERVENTION

Waitlist control (intervention will be available to this group at the end of the study period)

Interventions

Please refer to arm description

Mindful Awareness Practices (MAPs)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (7)

  • 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.

    PMID: 26695473BACKGROUND
  • 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.

    PMID: 24448053BACKGROUND
  • 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.

    PMID: 19341981BACKGROUND
  • 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.

    PMID: 29780891BACKGROUND
  • 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.

    PMID: 26347361BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Michael Irwin, MD

    University of California, Los Angeles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 3, 2018

Study Start

June 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations