Clinical trial NCT05561933: Scaling Well-Being for Educators During COVID-19
Official title: COVID-19 and the Healthy Minds Program for Educators II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Well-being
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Chan Zuckerberg Initiative
First posted: 2022-09-30
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

  1. Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component)
  2. Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months
  3. Previous use of the HMP app.
* PROMIS depression score greater than 70

Primary outcomes:
measure: 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).
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Secondary outcomes:
measure: Well-being (WHO-5)
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness and Non-react to Inner Experience Subscales
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change From Baseline on the NIH Toolbox Loneliness Scale.
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change From Baseline on the Lee Coronavirus Anxiety Scale (CAS)
timeFrame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change From Baseline on the Perseverative Thought Questionnaire
timeFrame: baseline, 4 weeks (post intervention)
measure: Change From Baseline on the Growth Mindset Scale for Well-Being
timeFrame: baseline, after weeks 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change from Baseline in Healthy Minds Index
timeFrame: baseline, after week 2, 4 weeks (post intervention)
measure: Change from Baseline in Perceived Stress Scale
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change from Baseline in Teacher Job Satisfaction Scale (TJSS-9) Questionnaire
timeFrame: baseline, after week 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change in Baseline in Positive Administrative Support Questionnaire (Appreciation and Trust Attributes)
timeFrame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change in Baseline in Rumination About Work at Home Survey
timeFrame: baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change in Baseline in Maslach Burnout Inventory (Emotional Exhaustion and Depersonalization Subscores)
timeFrame: baseline, week 4 (post intervention), 20 weeks (5 months post-intervention)
measure: Change in Baseline in Personal Wellbeing Index (PWI)
timeFrame: baseline, week 4 (post intervention), 20 weeks (5 months post-intervention)
measure: Change in Baseline in Sleep Quality
timeFrame: baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Persistence in the profession
timeFrame: 12-18 months after baseline
measure: Change from baseline on reflection rings / circles
timeFrame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Change from baseline on experience sampling measure of satisfaction and mood at work and at home
timeFrame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Other outcomes:
measure: Digital Working Alliance Inventory
timeFrame: after weeks 1, 2, and 3 (intervention group only)
measure: Social Desirability (SDRS-5)
timeFrame: baseline
measure: Predictor of Drop-out Questionnaire
timeFrame: baseline
measure: Determinants of Meditation Practice Inventory-Revised (DMPI-R)
timeFrame: baseline
measure: Adverse Meditation Experiences Questionnaire
timeFrame: 4 weeks (post intervention), 20 weeks (5 months post-intervention)
measure: Teacher effects on student change on standardized test scores
timeFrame: 6-months prior to baseline, baseline, 6-months, 18-months
measure: Teacher effects on student change on attendance
timeFrame: 6-months prior to baseline, baseline, 6-months, 18-months
measure: Teacher effects on student change on disciplinary referrals
timeFrame: 6-months prior to baseline, baseline, 6-months, 18-months
Locations:
city: Louisville
country: United States
facility: Jefferson County Public Schools
state: Kentucky
Study officials:
affiliation: UW-Madison
name: Matthew J Hirshberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.
citation: Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.
citation: Crain TL, Schonert-Reichl KA, Roeser RW. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes. J Occup Health Psychol. 2017 Apr;22(2):138-152. doi: 10.1037/ocp0000043. Epub 2016 May 16.
citation: Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
citation: Pepe A, Addimando L, Veronese G. Measuring Teacher Job Satisfaction: Assessing Invariance in the Teacher Job Satisfaction Scale (TJSS) Across Six Countries. Eur J Psychol. 2017 Aug 31;13(3):396-416. doi: 10.5964/ejop.v13i3.1389. eCollection 2017 Aug.
citation: Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
citation: Britton WB, Lindahl JR, Cooper DJ, Canby NK, Palitsky R. Defining and measuring meditation-related adverse effects in mindfulness-based programs. Clin Psychol Sci. 2021 May 18;9(6):1185-1204. doi: 10.1177/2167702621996340. Epub 2021 Nov 1.
citation: Brose, A., Raedt, R. D., & Vanderhasselt, M.-A. (2020). Eight items of the ruminative response scale are sufficient to measure weekly within-person variation in rumination. Current Psychology. https://doi.org/10.1007/s12144-020-00913-y
citation: Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
citation: Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
citation: Cyranowski JM, Zill N, Bode R, Butt Z, Kelly MA, Pilkonis PA, Salsman JM, Cella D. Assessing social support, companionship, and distress: National Institute of Health (NIH) Toolbox Adult Social Relationship Scales. Health Psychol. 2013 Mar;32(3):293-301. doi: 10.1037/a0028586.
citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
citation: Hays, R. D., Hayashi, T., & Stewart, A. L. (1989). A five-item measure of socially desirable response set. Educational and Psychological Measurement, 49(3), 629-636.
citation: International Wellbeing Group (2013). Personal Wellbeing Index: 5th Edition. Melbourne: Australian Centre on Quality of Life, Deakin University
citation: Goldberg SB, Imhoff-Smith T, Bolt DM, Wilson-Mendenhall CD, Dahl CJ, Davidson RJ, Rosenkranz MA. Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial. JMIR Ment Health. 2020 Nov 27;7(11):e23825. doi: 10.2196/23825.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.