Self-compassionNCT05051969
Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
A study testing Remote Mindfulness-Based Stress Reduction Program in people with Self-compassion and Burnout, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-compassion, Burnout, Stress
- What is being tested?
- Remote Mindfulness-Based Stress Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working certificated Metro Nashville Public Schools (MNPS) employees who self-report stress, anxiety, and/or depressive symptoms
Who cannot join
- Unable to commit to the weekly MBSR schedule
- Have taken the MBSR course previously
- Participants who do not have reliable home internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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.
- Conditions
- Self-compassion, Burnout, Stress, Anxiety, Depression
- Being tested
- Remote Mindfulness-Based Stress Reduction Program
- Keywords
- Burnout, Self-compassion
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Mindfulness-Based Stress Reduction ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 8 Week Remote Mindfulness-Based Stress Reduction Program | Experimental | 8 Week Remote MBSR Course for MNPS Employees. Receives: Behavioral: Remote Mindfulness-Based Stress Reduction Program |
| 8 week waitlist control | No intervention | 8 week waitlist control. They will complete the same assessments at baseline, 8 and 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Feasibility of recruitment will be assessed as the number of inviduals who are screened, eligible and enrolled in the study.
Measured: Baseline
Feasibility- class attendance
Percentage of participants that attend each scheduled session and who complete the program.
Measured: Baseline to program completion (8 weeks)
Feasibility- enrollment retention
Retention will be the number and proportion of indviduals who complete patient reported outcome data collection at 12-weeks.
Measured: Baseline to 12 weeks after enrollment
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.
Measured: Baseline to 8 weeks
Secondary outcomes (9)
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.
Measured: Baseline, 8 weeks and 12 weeks
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.
Measured: Baseline, 8 weeks and 12 weeks
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.
Measured: Baseline, 8 and 12 weeks after enrollment.
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.
Measured: Baseline, 8 and 12 weeks after enrollment.
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.
Measured: Baseline, 8 and 12 weeks after enrollment.
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.
Measured: Baseline, 8 and 12 weeks after enrollment.
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.)
Measured: Baseline, 8 and 12 weeks after enrollment.
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.)
Measured: Baseline, 8 and 12 weeks after enrollment.
Acceptability - Satisfaction
)pen-ended questions regarding barriers and facilitators of adherence and suggestions for improving the MBSR program experience
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Jul 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-compassionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha E. Shepherd, Vanderbilt University Medical Center
- Investigators
- Martha E Shepherd, DO, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051969
- Sponsor's protocol ID
- 211257
- Status last verified
- Feb 2023
- First submitted
- 12 Sep 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees
- ClinicalTrials.gov ID
- NCT05051969
- Acronym / sponsor ID
- 211257
- Conditions
- Self-compassion, Burnout, Stress, Anxiety, Depression
- Keywords
- Burnout, Self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 Week Remote Mindfulness-Based Stress Reduction Program | Experimental | Behavioral: Remote Mindfulness-Based Stress Reduction Program8 Week Remote MBSR Course for MNPS Employees. |
| 8 week waitlist control | No intervention | –8 week waitlist control. They will complete the same assessments at baseline, 8 and 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Working certificated Metro Nashville Public Schools (MNPS) employees who self-report stress, anxiety, and/or depressive symptoms
Key exclusion criteria (3 listed)
- Unable to commit to the weekly MBSR schedule
- Have taken the MBSR course previously
- Participants who do not have reliable home internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Mindfulness-Based Stress Reduction ProgramEnrolled 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. | Behavioural | 8 Week Remote Mindfulness-Based Stress Reduction Program |
Primary outcome
Feasibility - Recruitment
Time frame: Baseline
Feasibility of recruitment will be assessed as the number of inviduals who are screened, eligible and enrolled in the study.
Feasibility- class attendance
Time frame: Baseline to program completion (8 weeks)
Percentage of participants that attend each scheduled session and who complete the program.
Feasibility- enrollment retention
Time frame: Baseline to 12 weeks after enrollment
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
Time frame: Baseline to 8 weeks
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.
9 secondary outcomes
Perceived stress as measured by a Perceived Stress Scale
Time frame: Baseline, 8 weeks and 12 weeks
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form
Time frame: Baseline, 8 weeks and 12 weeks
Depression as measured by the PROMIS Depression short form
Time frame: Baseline, 8 and 12 weeks after enrollment.
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
Time frame: Baseline, 8 and 12 weeks after enrollment.
Physical health as measured by the 6-item Short Form Health Survey within the (SF-12)
Time frame: Baseline, 8 and 12 weeks after enrollment.
Mental health as measured by the 6-item Short Form Health Survey (SF-12)
Time frame: Baseline, 8 and 12 weeks after enrollment.
Self-compassion as measured by the Self-Compassion Scale (SCS)
Time frame: Baseline, 8 and 12 weeks after enrollment.
Educator burnout as measured by the Maslach Burnout Inventory-Educator's Survey
Time frame: Baseline, 8 and 12 weeks after enrollment.
Acceptability - Satisfaction
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Self-compassion
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Recruiting
Hope-Focused Motivational Interviewing in Cancer Patients
Motivational Intervention, Cancer
Active, not recruiting
Strategic Thinking and Shaping the Future Training for Midwives' Self-Leadership and Self-Compassion
Self-Leadership, Self-Compassion
Recruiting
The Impact of a Nursing Care Program Based on Human Caring Theory on Adolescents With Self-harm
Self Harm
Active, not recruiting
RISE for Nurse Preceptors
Mental Health, Resilience
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha E Shepherd, DO, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Mindfulness-Based Stress Reduction Program in people with Self-compassion and Burnout, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.