COVID-19 and the Healthy Minds Program for Educators II
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 829
- Locations
- 2
- Primary Endpoint
- 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).
Study Overview
Brief 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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The investigator and data analyst will not know condition assignment until after data analyses are complete.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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).
Time Frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
A and B: Adaptive 4-8 item self-report scale. C: 10-item self-report. Higher scores indicate greater symptoms of psychological distress.
Secondary Outcomes
- Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness and Non-react to Inner Experience Subscales(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)(baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change From Baseline on the NIH Toolbox Loneliness Scale.(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change from Baseline in Healthy Minds Index(baseline, after week 2, 4 weeks (post intervention))
- Well-being (WHO-5)(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(baseline, after week 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change From Baseline on the Perseverative Thought Questionnaire(baseline, 4 weeks (post intervention))
- Change in Baseline in Maslach Burnout Inventory (Emotional Exhaustion and Depersonalization Subscores)(baseline, week 4 (post intervention), 20 weeks (5 months post-intervention))
- Change in Baseline in Personal Wellbeing Index (PWI)(baseline, week 4 (post intervention), 20 weeks (5 months post-intervention))
- Change in Baseline in Sleep Quality(baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change From Baseline on the Growth Mindset Scale for Well-Being(baseline, after weeks 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change in Baseline in Rumination About Work at Home Survey(baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change from baseline on reflection rings / circles(baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Persistence in the profession(12-18 months after baseline)
- Change from Baseline in Perceived Stress Scale(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention))
- Change in Baseline in Positive Administrative Support Questionnaire (Appreciation and Trust Attributes)(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(baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention))