Scaling Well-Being for Educators During COVID-19

Study Overview
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Brief Summary
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This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of Jefferson County Public Schools (JCPS) in Louisville, KY. The study will enroll 1300 JCPS employees. After completing the baseline assessment, participants will be randomly assigned to the intervention (i.e., the Healthy Minds Program App) or to a Choice control condition. HMP assigned participants will receive instructions and support in downloading and activating the app. Choice assigned participants will receive a list of resources that are focused on the science of well-being and happiness consisting of TED talk videos and books. 10 copies of each suggested book will be available for participants to check out. TED talk video links will be provided and are free to watch. Each week during the 4-week intervention period, participants in both conditions will complete the same weekly set of measures. Within two-weeks following the end of the intervention period, all participants will complete the post-test assessment. Approximately five to six months following post-test, participants will complete the follow-up assessment. In addition to study team collected data, the research team will receive from the district multiple years of student records (e.g., standardized assessments, attendance, disciplinary referrals) linked to teachers (teachers only, not other categories of employees who choose to participate). The researchers predict that participants assigned to the intervention will demonstrate significantly reduced anxiety and depressive symptoms and significantly improved well-being after the intervention, and these improvements will persist at the follow-up (primary outcomes). It is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes. In addition, the investigators predict that intervention period improvements on well-being skills assessed weekly will mediate long-term improvements on primary outcomes.

Detailed Description
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This study is a conceptual replication of COVID and the Healthy Minds for Educators (NCT04426318). It will test whether training in well-being practices, using the Healthy Minds Program (HMP) app, is beneficial for employees in Jefferson County Public Schools (JCPS) in Louisville, Kentucky. The goal is to extend the prior study by recruiting a larger and more diverse sample of participants and examining whether intervening at the staff level positively affects student outcomes. The HMP app approaches cultivating well-being by training psychological skills with clear mechanistic hypotheses. There is no single definition of well-being, but consensus exists that positive functioning beyond the absence of detrimental mental health symptoms is central. Building on related eudaimonic frameworks of psychological flourishing that identify qualities like environmental mastery, positive relations with others, and personal growth, this program targets brain-based skills that underlie the active cultivation of such qualities (e.g., regulating attention, empathic care, mental flexibility), and thus offers straightforward hypotheses about mechanisms of change. The cultivation of such skills aligns with the World Health Organization's definition of mental health, as a state of well-being in which an individual can work productively, cope with the normal stresses of life, contribute to his or her community, and realize his or her own abilities. Viewing well-being as dynamic and skill-based, as opposed to static and set, brings new optimism to cultivating well-being across the lifespan. The HMP app involves mental exercises that are integrated into daily life, with an approach that parallels the way physical exercise becomes a part of healthy living. A minority of the population is both free of mental illness and high in well-being. This group flourishes mentally and physically (e.g., fewest days of missed work, healthiest psychosocial functioning, lowest risk of cardiovascular disease, lowest health care utilization). Troubling mental health trends in the opposite direction, however, underscore the need for training that bolsters and sustains well-being. National survey data recently revealed that 75% of Americans are significantly impacted by stress (e.g., anxiety, sleeplessness, fatigue), a new high since the survey's inception in 2007. Social divisiveness is an alarming new theme in these reports (59% identified this as a cause of stress), especially given rising trends of social isolation in which people report far fewer trusted confidants (this isolation is even more pronounced now with safer at home orders). Whereas mental health interventions have traditionally focused on treating serious mental disorders, this program advocates training and practicing skills even when an individual is relatively healthy. In this framework, exercising these skill sets bolsters well-being and fosters future resilience during inevitable periods of stress and loss. This program offers an innovative public health approach to caring for the mind. By investigating the underlying mechanisms, the investigators will understand whether this potentially transformative approach is viable.

Official Title
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COVID-19 and the Healthy Minds Program for Educators II

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Healthy Minds Program Foundations Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 years old and up Employee of participating district/state Smartphone or device that can download apps from Google Play or the iTunes app store Exclusion Criteria: Individuals under 18 years old Significant meditation experience: Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component) Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months Previous use of the HMP app. PROMIS depression score greater than 70

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Choice Group<br>Participants assigned to the Choice group will receive a list of digital (i.e., links to TED talks) and hard-copy (i.e., books) resources that focus on the science of well-being and may support well-being. It is up to participants whether and to what extent they choose to engage with these resources. A study library with 10 copies of each recommended book will be accessible to participants should they wish to read any of the suggested books. After follow-up testing, Choice group participants will be provided free access to the HMP training. | Behavioral: Healthy Minds Program Foundations Training<br>* The HMP was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on decades of research on well-being. The program is delivered through a smartphone application and consists of didactic (learns) and experiential (practice) components. Practice components involve contemplative practices such as mindfulness, loving-kindness, and gratitude practices. Each practice allows participants to choose duration (between 5-30 minutes). In addition to sitting style practices common in other meditation apps/programs, the HMP also provides instruction in active practices. Active practices engage the same skills as sitting practice, but focus on strengthening skills during daily routines. Learn components provide psycho-educational content about the science of well-being. HMP learns and practices are based on a four pillar model of well-being skills consisting of Awareness, Connection, Insight, and Purpose.<br>|
| Experimental: Healthy Minds Program (HMP) Group<br>Participants in the experimental arm will be assigned to the Healthy Minds Program Foundations training (HMP) which consists of 30-days of didactic and experiential content in a scientifically-derived model of well-being. A second random assignment will occur among intervention participants in which participants will receive the standard Foundations training or the Foundations training plus once per day push notifications (i.e., a micro-interventions) that provide a very brief opportunity to practice with the HMP content of that day. HMP participants will not be made aware of this second assignment. | Behavioral: Healthy Minds Program Foundations Training<br>* The HMP was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on decades of research on well-being. The program is delivered through a smartphone application and consists of didactic (learns) and experiential (practice) components. Practice components involve contemplative practices such as mindfulness, loving-kindness, and gratitude practices. Each practice allows participants to choose duration (between 5-30 minutes). In addition to sitting style practices common in other meditation apps/programs, the HMP also provides instruction in active practices. Active practices engage the same skills as sitting practice, but focus on strengthening skills during daily routines. Learn components provide psycho-educational content about the science of well-being. HMP learns and practices are based on a four pillar model of well-being skills consisting of Awareness, Connection, Insight, and Purpose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on Psychological distress: Z-scored aggregate of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (a) and Anxiety (b) Scales, and the NIH Toolbox Perceived Stress v2.0 (c). | A and B: Adaptive 4-8 item self-report scale. C: 10-item self-report. Higher scores indicate greater symptoms of psychological distress. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being (WHO-5) | The World Health Organization Five Well-Being Index (WHO-5) is a short self-reported measure of current mental well-being (time frame the previous two weeks). The scale score range is 0 (lowest possible well-being) to 25 (highest possible well-being. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness and Non-react to Inner Experience Subscales | A measure of acting with mindful awareness and not reacting to experience. Total possible scores range from 8-40, with higher scores indicating greater levels of the facet of mindfulness. These constructs are specified as a mechanism of change. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change From Baseline on the NIH Toolbox Loneliness Scale. | A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness. This construct is specified as a mechanism of change. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change From Baseline on the Lee Coronavirus Anxiety Scale (CAS) | The Coronavirus Anxiety Scale (CAS) is a brief mental health screener to identify probable cases of dysfunctional anxiety associated with the COVID-19 crisis. The scale score range is 0 (lowest possible anxiety) to 20 (highest possible anxiety). | baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change From Baseline on the Perseverative Thought Questionnaire | Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking. | baseline, 4 weeks (post intervention) | 
| Change From Baseline on the Growth Mindset Scale for Well-Being | A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned). This construct is specified as a mechanism of change. | baseline, after weeks 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change from Baseline in Healthy Minds Index | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality. | baseline, after week 2, 4 weeks (post intervention) | 
| Change from Baseline in Perceived Stress Scale | The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., In the last month, how often have you felt nervous and 'stressed'?). It is scored on a 5-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change from Baseline in Teacher Job Satisfaction Scale (TJSS-9) Questionnaire | The Teacher Job Satisfaction Scale (Pepe, 2011) is a questionnaire aimed at measuring job satisfaction in educational contexts. The TJSS-9 is composed of three dimensions: satisfaction with co-workers (3 items), satisfaction with parents (3 items) and satisfaction with students' behaviors (3 items). Items are rated on a 5-point scale (1 = I am highly dissatisfied with this aspect of the school, 5 = I am highly satisfied with this aspect of the school). | baseline, after week 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change in Baseline in Positive Administrative Support Questionnaire (Appreciation and Trust Attributes) | The Positive Administrative Support survey examines the effects of perceived administrative support on teacher stress, job satisfaction, and school commitment with intent to stay in the field. The appreciation subscale consists of 3 items with scale scores ranging from 0 (lowest appreciation) to 15 (highest appreciation). The trust subscale consists of 4 items with scale scores ranging from 0 (lowest trust) to 20 (highest trust). | baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change in Baseline in Rumination About Work at Home Survey | Participants express their perceptions of their work-home conflict with three statements scored on a five-point scale (1 = not at all true of me, 5 = very true of me). Higher scores indicate more work-home conflict. | baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change in Baseline in Maslach Burnout Inventory (Emotional Exhaustion and Depersonalization Subscores) | Burn-out is a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed. Participants will use a 7-point frequency scale (ranging from 0-never to 6-daily) to indicate the extent to which they experienced each item (e.g., I feel emotionally drained from my work.). Higher scores indicate higher degrees of burnout. | baseline, week 4 (post intervention), 20 weeks (5 months post-intervention) | 
| Change in Baseline in Personal Wellbeing Index (PWI) | The PWI is a single question asking how satisfied the respondent feels in their life and personal circumstances on a Likert scale of 0 (no satisfaction at all) to 10 (completely satisfied), with higher scores indicating more satisfaction. | baseline, week 4 (post intervention), 20 weeks (5 months post-intervention) | 
| Change in Baseline in Sleep Quality | Four items from the Pittsburgh Sleep Quality Index will be used to evaluate overall sleep quality, average nightly hours slept, use of sleep medications, and problems staying awake. All items except average nightly sleep are rated on a 1 (best) to 4 (worst) scale. The average nightly hours of sleep is scored so that >7 hrs a night (1), 6-7 hrs a night (2), 5-6 hrs a night (3), and <5 hrs a night (4). The four items are then averaged for an overall index of sleep quality. | baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Persistence in the profession | Using employment records provided by the district, investigators will compare the odds of continuing in the profession between the intervention and control groups in the 2023-2024 school year. | 12-18 months after baseline | 
| Change from baseline on reflection rings / circles | A gamified measure of allocentric circles measuring sense of connection. The task ask participants to move the degree to which two circles (one represents self, one an object) overlap as an indication of their feeling of connection with the object. Objects are others (e.g., friends, loved ones, parents, stranger) and things from the natural world (e.g., animals, eagle, trees). Rankings range from 0 (no overlap/no connection) t0 9 (complete overlap, indistinguishable). There is a total score (average of all items) as well as average scores on others and natural world items. | baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 
| Change from baseline on experience sampling measure of satisfaction and mood at work and at home | A measure of satisfaction and mood at work and at home assessed 3 times a day, for 3 days. Scores on work life, job and home life satisfaction range from 1 (Not at all) to 5 (extremely) and scores on mood at work and mood at home range from 1 (very disatisfied) to 5 (very satisfied). Mood at work and home items rate the percentage of time a participants is in an irritable or bad mood at each place from 1 (0-25% of the time) to 4 (75-100% of the time). | baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Well-being