NCT04307563

Brief Summary

The primary aims of the study are to 1) provide a hospital employee population with a mindfulness based stress reduction workshop and 2) evaluate the impact of this clinically validated group mindfulness intervention on burnout in health care employees. Secondary outcomes will be anxiety, depression, quality of life and self compassion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

March 11, 2020

Last Update Submit

December 8, 2022

Conditions

Keywords

self-compassionmeditationhealth personnel

Outcome Measures

Primary Outcomes (1)

  • Change in Burnout

    1\. Differences in Burnout scale between time points The Burnout Scale has been validated by Trockel et al. (2018).It is composed of two subscales (emotional exhaustion containing 4 questions and interpersonal disengagement containing 6 questions.) Both scales are scored on a Likert scale of 0 to 4 ("not at all" to "extremely"). For total Burnout score, the scores of the combined scale (10 total) are averaged. The higher scores indicate higher levels of overall burnout. Individual subscale means will also be computed (with higher scores indicating higher amounts of emotional exhaustion and interpersonal disengagement. Difference in overall burnout measured at four time points (week 1 and 6 of the intervention and 3 \& 6 months post intervention) will be reported and compared. The composite scales take approximately 2 minutes to complete.

    Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

Secondary Outcomes (4)

  • Change in Anxiety

    Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  • Change in Depression

    Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  • Change in Perceived Health

    Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  • Change in compassion

    Four time points (week 1 and 6 of intervention, and 3 & 6 months post intervention)

Study Arms (1)

Mindfulness group

OTHER

Participants will attend 6 weekly educational and mindfulness sessions.

Behavioral: Mindfulness session

Interventions

1.5 hour weekly session with health educator

Mindfulness group

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Employees of Stanford Health Care
  • Ability to attend a minimum of 4 out of 6 sessions

You may not qualify if:

  • Non-English speaking
  • Employees with severe medical or psychiatric conditions that prevent them from participating in the group format

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Palo Alto, California, 94305, United States

Location

Related Publications (9)

  • Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting. J Workplace Behav Health. 2013 Apr;28(2):107-133. doi: 10.1080/15555240.2013.779518.

    PMID: 23667348BACKGROUND
  • Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.

    PMID: 12387650BACKGROUND
  • Vollestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012 Sep;51(3):239-60. doi: 10.1111/j.2044-8260.2011.02024.x. Epub 2011 Sep 9.

    PMID: 22803933BACKGROUND
  • Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.

    PMID: 23541163BACKGROUND
  • DeSalvo KB, Jones TM, Peabody J, McDonald J, Fihn S, Fan V, He J, Muntner P. Health care expenditure prediction with a single item, self-rated health measure. Med Care. 2009 Apr;47(4):440-7. doi: 10.1097/MLR.0b013e318190b716.

    PMID: 19238099BACKGROUND
  • Zich JM, Attkisson CC, Greenfield TK. Screening for depression in primary care clinics: the CES-D and the BDI. Int J Psychiatry Med. 1990;20(3):259-77. doi: 10.2190/LYKR-7VHP-YJEM-MKM2.

    PMID: 2265888BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PMID: 21584907BACKGROUND
  • Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.

    PMID: 29196982BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Maria G Juarez-Reyes

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Alexandria Blacker

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

September 1, 2021

Primary Completion

July 5, 2022

Study Completion

July 5, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations