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OpenTrials
Completed

NCT Number: NCT04307563

Effects of Mindfulness Training on Burnout and Mood in Hospital Employees

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness session

Behavioral

1.5 hour weekly session with health educator

Primary outcomes

  1. Change in Burnout

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

    • 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.

Secondary outcomes

  1. Change in Anxiety

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

    • 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.

  2. Change in Depression

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

    • 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.

  3. Change in Perceived Health

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

    • 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.

  4. Change in compassion

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

    • 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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