Effects of Mindfulness Training on Burnout and Mood in Hospital Employees
Primary Purpose
Anxiety Depression, Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness session
Sponsored by
About this trial
This is an interventional other trial for Anxiety Depression focused on measuring self-compassion, meditation, health personnel
Eligibility Criteria
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
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mindfulness group
Arm Description
Participants will attend 6 weekly educational and mindfulness sessions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Anxiety
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.
Change in Depression
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.
Change in Perceived Health
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.
Change in compassion
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04307563
Brief Title
Effects of Mindfulness Training on Burnout and Mood in Hospital Employees
Official Title
Behavioral Health Support for Health Care Providers During COVID 19: A Remote Mindfulness Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Depression, Burnout
Keywords
self-compassion, meditation, health personnel
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness group
Arm Type
Other
Arm Description
Participants will attend 6 weekly educational and mindfulness sessions.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness session
Intervention Description
1.5 hour weekly session with health educator
Primary Outcome Measure Information:
Title
Change in Burnout
Description
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.
Time Frame
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Secondary Outcome Measure Information:
Title
Change in Anxiety
Description
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.
Time Frame
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Title
Change in Depression
Description
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.
Time Frame
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Title
Change in Perceived Health
Description
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.
Time Frame
Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)
Title
Change in compassion
Description
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.
Time Frame
Four time points (week 1 and 6 of intervention, and 3 & 6 months post intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria G Juarez-Reyes
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandria Blacker
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23667348
Citation
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Results Reference
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12387650
Citation
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.
Results Reference
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PubMed Identifier
22803933
Citation
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.
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Effects of Mindfulness Training on Burnout and Mood in Hospital Employees
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