Effects of Mindfulness Training on Burnout and Mood in Hospital Employees

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04307563
Collaborator
(none)
60
1
1
18.9
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness session
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mindfulness Effects on Burnout and Mood in Hospital Employees
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Burnout [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.

Secondary Outcome Measures

  1. Change in Anxiety [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.

  2. Change in Depression [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.

  3. Change in Perceived Health [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.

  4. Change in compassion [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Health Care Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maria Juarez-Reyes, Assistant Clinical Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT04307563
Other Study ID Numbers:
  • IRB-54792
First Posted:
Mar 13, 2020
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Juarez-Reyes, Assistant Clinical Professor, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022