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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05561933
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Active, not recruiting
Phase N/A
Start date October 21, 2022
Completion date September 1, 2025

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