Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
Primary Purpose
Self-compassion, Burnout, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Mindfulness-Based Stress Reduction Program
Sponsored by
About this trial
This is an interventional other trial for Self-compassion focused on measuring Burnout, Self-compassion
Eligibility Criteria
Inclusion Criteria:
- Working certificated Metro Nashville Public Schools (MNPS) employees who self-report stress, anxiety, and/or depressive symptoms
Exclusion Criteria:
- Unable to commit to the weekly MBSR schedule
- Have taken the MBSR course previously
- Participants who do not have reliable home internet
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
8 Week Remote Mindfulness-Based Stress Reduction Program
8 week waitlist control
Arm Description
8 Week Remote MBSR Course for MNPS Employees.
8 week waitlist control. They will complete the same assessments at baseline, 8 and 12 weeks
Outcomes
Primary Outcome Measures
Feasibility - Recruitment
Feasibility of recruitment will be assessed as the number of inviduals who are screened, eligible and enrolled in the study.
Feasibility- class attendance
Percentage of participants that attend each scheduled session and who complete the program.
Feasibility- enrollment retention
Retention will be the number and proportion of indviduals who complete patient reported outcome data collection at 12-weeks.
Acceptability - Overall Helpfulness of the course
Helpfulness of the course assessed by a one question survey with an 11-point Numeric Rating Scale ranging from 0 ("Not helpful") to 10 ("Most helpful"). Lower scores indicate less helpfulness.
Secondary Outcome Measures
Perceived stress as measured by a Perceived Stress Scale
10-item Perceived Stress Scale. Each question is scored ranging from 0 (Never) to 4 (Very Often) Total survey scores range from 0-40. A lower score indicates low stress, a better outcome.
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form
4-item Anxiety short form. Each question is scored ranging from 1 (Never) to 5 (Always). Total raw scores range from 4-20. A lower score indicates low anxiety, a better outcome.
Depression as measured by the PROMIS Depression short form
4-item depression short form. Each question is scored ranging from 1 (Never) to 5 (Always). Total raw scores range from 4-20. A lower score indicates low depression, a better outcome.
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
15-item mindfulness questionnaire. Each question is scored from 1 (Never or very rarely true) to 5 (Very often or always true). Total raw scores range from 15-75. A higher score indicates more mindfulness, a better outcome.
Physical health as measured by the 6-item Short Form Health Survey within the (SF-12)
6 item health survey. The questions vary in scoring and answers with question 1 scores ranging from 1(Excellent) to 5 (Poor). Questions 2-3 scoring ranges from 1 (Yes, limited a lot) to 3 (No, not limited at all). Questions 4-7 scoring ranges from 1 (Yes) to 2 (No). Question 8 scoring ranges from 1 (Not at all) to 5 (Extremely). Questions 9-11 scoring ranges from 1 (All of the time) to 6 (None of the time). Question 12 scoring ranges from 1 (All of the time) to 5 (None of the time).
Total raw score range from 0-100. A higher score indicates better physical function, a better outcome.
Mental health as measured by the 6-item Short Form Health Survey (SF-12)
6 item health survey. The questions vary in scoring and answers with question 1 scores ranging from 1(Excellent) to 5 (Poor). Questions 2-3 scoring ranges from 1 (Yes, limited a lot) to 3 (No, not limited at all). Questions 4-7 scoring ranges from 1 (Yes) to 2 (No). Question 8 scoring ranges from 1 (Not at all) to 5 (Extremely). Questions 9-11 scoring ranges from 1 (All of the time) to 6 (None of the time). Question 12 scoring ranges from 1 (All of the time) to 5 (None of the time).
Total raw score range from 0-100. A higher score indicates better mental health, a better outcome.
Self-compassion as measured by the Self-Compassion Scale (SCS)
26 item compassion scale. Each question is scored ranging from 1 (Almost never) to 5 Almost always). Scoring encompasses subscale measurements of: self kindness (Total raw scores range from 5-25. A high score indicating more self-kindness, a better outcome.), self judgement ( Total raw scores range from 5-25. A low score indicates low self-judgement, a better outcome.), common humanity items (Total raw score range from 4-20. A higher score indicates more common humanity, a better outcome.), isolation (Total raw score range from 4-20. A lower score indicates low feelings of isolation, a better outcome.), mindfulness (Total raw scores range from 4-20. A higher score indicates more mindfulness, a better outcome.), over-identified (Total raw scores range from 4-20. A low score indicates low over-identifying behaviors, a better outcome.)
Educator burnout as measured by the Maslach Burnout Inventory-Educator's Survey
22-item Burnout survey for educators. Each question is scored ranging from 0 (Never) to 6 (Every day). Scoring encompasses subcscale measurements of emotional exhaustion (Total raw score range from 0-54. A lower score indicates lower emotional exertion, a better outcome), depersonalization ( Total raw scores range from 0-30. A lower score indicates lower feelings of depersonalization, a better outcome.), and personal accomplishment (Total raw scores range from 0-48 A higher score indicates higher personal accomplishment, a better outcome.)
Acceptability - Satisfaction
)pen-ended questions regarding barriers and facilitators of adherence and suggestions for improving the MBSR program experience
Full Information
NCT ID
NCT05051969
First Posted
September 12, 2021
Last Updated
February 7, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05051969
Brief Title
Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
Official Title
Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
January 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
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
Stress, anxiety, and depression are common symptoms among public school teachers. Public school teachers are among the top professions reporting stress, anxiety, and depression. The causes are multifactorial and include work-related demands, challenges with students, limited resources, and compassion fatigue. Because of this, teachers are at risk of burnout and leaving or changing their profession. The COVID-19 pandemic has had a considerable impact on teachers due to disruptions in usual education delivery and ability to support students. Recent reports show poorer mental health and decreases in physical activity in teachers since the onset of the pandemic. Effective and implementable strategies are urgently needed to address poor mental health and to foster positive health characteristics in this population.
Mindfulness programs decrease feelings of stress, anxiety, and emotional exhaustion. Additionally, mindfulness can improve self-compassion, which may be an important mediating factor in a teacher population. Prior work has shown an inverse relationship between self-compassion and burnout. Currently, there are few studies investigating whether building self-compassion can reduce burnout in public school teachers. The investigators will explore therelationship between participation in a Mindfulness-Based Stress Reduction (MBSR) course and changes in burnout, self-compassion, and other whole person health measures in an educator population. The overall objective of this open pilot study is to examine the feasibility and acceptability of an 8-week remote, group-based MBSR program delivered over Zoom for Metro Nashville Public Schools (MNPS) personnel reporting elevated stress, anxiety, and/or depressive symptoms. Our pilot study results will contribute to the evidence on MBSR in a public-school employee population and inform strategies to optimize implementation of our remote MBSR program within the Vanderbilt Health at MNPS system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-compassion, Burnout, Stress, Anxiety, Depression
Keywords
Burnout, Self-compassion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 Week Remote Mindfulness-Based Stress Reduction Program
Arm Type
Experimental
Arm Description
8 Week Remote MBSR Course for MNPS Employees.
Arm Title
8 week waitlist control
Arm Type
No Intervention
Arm Description
8 week waitlist control. They will complete the same assessments at baseline, 8 and 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Remote Mindfulness-Based Stress Reduction Program
Intervention Description
Enrolled participants will participate in a remote-delivered (online with audio and video) Mindfulness-Based Stress Reduction (MBSR) program. MBSR is a well established behavioral health intervention consisting of 10-sessions lasting 2.5 hours, with one session lasting 7.5 hours in an all-day retreat format over a 2-month period.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Feasibility of recruitment will be assessed as the number of inviduals who are screened, eligible and enrolled in the study.
Time Frame
Baseline
Title
Feasibility- class attendance
Description
Percentage of participants that attend each scheduled session and who complete the program.
Time Frame
Baseline to program completion (8 weeks)
Title
Feasibility- enrollment retention
Description
Retention will be the number and proportion of indviduals who complete patient reported outcome data collection at 12-weeks.
Time Frame
Baseline to 12 weeks after enrollment
Title
Acceptability - Overall Helpfulness of the course
Description
Helpfulness of the course assessed by a one question survey with an 11-point Numeric Rating Scale ranging from 0 ("Not helpful") to 10 ("Most helpful"). Lower scores indicate less helpfulness.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Perceived stress as measured by a Perceived Stress Scale
Description
10-item Perceived Stress Scale. Each question is scored ranging from 0 (Never) to 4 (Very Often) Total survey scores range from 0-40. A lower score indicates low stress, a better outcome.
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form
Description
4-item Anxiety short form. Each question is scored ranging from 1 (Never) to 5 (Always). Total raw scores range from 4-20. A lower score indicates low anxiety, a better outcome.
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Depression as measured by the PROMIS Depression short form
Description
4-item depression short form. Each question is scored ranging from 1 (Never) to 5 (Always). Total raw scores range from 4-20. A lower score indicates low depression, a better outcome.
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
Description
15-item mindfulness questionnaire. Each question is scored from 1 (Never or very rarely true) to 5 (Very often or always true). Total raw scores range from 15-75. A higher score indicates more mindfulness, a better outcome.
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Physical health as measured by the 6-item Short Form Health Survey within the (SF-12)
Description
6 item health survey. The questions vary in scoring and answers with question 1 scores ranging from 1(Excellent) to 5 (Poor). Questions 2-3 scoring ranges from 1 (Yes, limited a lot) to 3 (No, not limited at all). Questions 4-7 scoring ranges from 1 (Yes) to 2 (No). Question 8 scoring ranges from 1 (Not at all) to 5 (Extremely). Questions 9-11 scoring ranges from 1 (All of the time) to 6 (None of the time). Question 12 scoring ranges from 1 (All of the time) to 5 (None of the time).
Total raw score range from 0-100. A higher score indicates better physical function, a better outcome.
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Mental health as measured by the 6-item Short Form Health Survey (SF-12)
Description
6 item health survey. The questions vary in scoring and answers with question 1 scores ranging from 1(Excellent) to 5 (Poor). Questions 2-3 scoring ranges from 1 (Yes, limited a lot) to 3 (No, not limited at all). Questions 4-7 scoring ranges from 1 (Yes) to 2 (No). Question 8 scoring ranges from 1 (Not at all) to 5 (Extremely). Questions 9-11 scoring ranges from 1 (All of the time) to 6 (None of the time). Question 12 scoring ranges from 1 (All of the time) to 5 (None of the time).
Total raw score range from 0-100. A higher score indicates better mental health, a better outcome.
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Self-compassion as measured by the Self-Compassion Scale (SCS)
Description
26 item compassion scale. Each question is scored ranging from 1 (Almost never) to 5 Almost always). Scoring encompasses subscale measurements of: self kindness (Total raw scores range from 5-25. A high score indicating more self-kindness, a better outcome.), self judgement ( Total raw scores range from 5-25. A low score indicates low self-judgement, a better outcome.), common humanity items (Total raw score range from 4-20. A higher score indicates more common humanity, a better outcome.), isolation (Total raw score range from 4-20. A lower score indicates low feelings of isolation, a better outcome.), mindfulness (Total raw scores range from 4-20. A higher score indicates more mindfulness, a better outcome.), over-identified (Total raw scores range from 4-20. A low score indicates low over-identifying behaviors, a better outcome.)
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Educator burnout as measured by the Maslach Burnout Inventory-Educator's Survey
Description
22-item Burnout survey for educators. Each question is scored ranging from 0 (Never) to 6 (Every day). Scoring encompasses subcscale measurements of emotional exhaustion (Total raw score range from 0-54. A lower score indicates lower emotional exertion, a better outcome), depersonalization ( Total raw scores range from 0-30. A lower score indicates lower feelings of depersonalization, a better outcome.), and personal accomplishment (Total raw scores range from 0-48 A higher score indicates higher personal accomplishment, a better outcome.)
Time Frame
Baseline, 8 and 12 weeks after enrollment.
Title
Acceptability - Satisfaction
Description
)pen-ended questions regarding barriers and facilitators of adherence and suggestions for improving the MBSR program experience
Time Frame
Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Working certificated Metro Nashville Public Schools (MNPS) employees who self-report stress, anxiety, and/or depressive symptoms
Exclusion Criteria:
Unable to commit to the weekly MBSR schedule
Have taken the MBSR course previously
Participants who do not have reliable home internet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha E Shepherd, DO, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
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