Effects of Mindfulness Training on Burnout and Mood in Hospital Employees

December 8, 2022 updated by: Maria Juarez-Reyes, Stanford University

Behavioral Health Support for Health Care Providers During COVID 19: A Remote Mindfulness Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Health Care

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mindfulness group
Participants will attend 6 weekly educational and mindfulness sessions.
Behavioral: Mindfulness session
1.5 hour weekly session with health educator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Burnout
Time Frame: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety
Time Frame: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

1. Differences in GAD-7 between time points.

The Generalized Anxiety Disorder-7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3). Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Differences in GAD-7 measured at four time points (week 1 and 6 of the intervention and 3 & 6 months post intervention) will be reported and compared. The scale takes approximately 2 minutes.
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Change in Depression
Time Frame: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

1. Differences in CES-D between time points.

The Center for Epidemiological Studies - Depression scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3). Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D in 2019 measured at four time points (week 1 and 6 of the intervention and 3 & 6 month post intervention) will be reported and compared. The scale takes approximately 5 minutes to complete.
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Change in Perceived Health
Time Frame: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

1. Differences in GSRH between time points.

A single item of the Health Related Quality of Life - 4 questionnaire "In general, would you say your health is Excellent (score 1), Very Good (score 2), Good (score 3), Fair (score 4), or Poor (score 5), the general self-rated health (GSRH), is a strong predictor of future health care utilization and mortality. It also has excellent validity. Higher scores of the GSRH are related to higher health care expenditures. Difference in GSRH measured at four time points (week 1 and 6 of the intervention and 3 & 6 month post intervention) will be reported and compared. The scale takes less than 1 minute to complete.
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Change in compassion
Time Frame: Four time points (week 1 and 6 of intervention, and 3 & 6 months post intervention)

1. Differences in compassion scores between time points.

The 12 item Self-Compassion Scale - Short Form is strongly validated scale to measure self-compassion or "the ability to hold one's feelings of suffering with a sense of warmth, connection and concern". Higher levels of self-compassion are associated with less depression and anxiety. Five-point Likert score are from 1 ("Almost Never") to 5 ("Almost Always"). Total score is computed by reverse scoring negative items of self-judgement, isolation and over-identification (ie 1=5, 2=4, 3=3, 4=2, 5=1) and computing total mean. Difference in Compassion measured at four time points (week 1 and 6 of the intervention, and 3 & 6 month post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.
Four time points (week 1 and 6 of intervention, and 3 & 6 months post intervention)

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Maria G Juarez-Reyes, Stanford University
  • Study Director: Alexandria Blacker, Stanford University

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)

September 1, 2021

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-54792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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