Scaling Well-Being for Educators During COVID-19

NCT05561933 | Completed

• 3 other identifiers: 2022-0313IRB Approval Date: 08/16/2022A483000
• Study Type: interventional
• Target: 829
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

Well-being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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 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 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 on the Lee Coronavirus Anxiety Scale (CAS)

  baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)

• Change From Baseline on the Perseverative Thought Questionnaire

  baseline, 4 weeks (post intervention)

Other Outcomes (8)

• Digital Working Alliance Inventory

  after weeks 1, 2, and 3 (intervention group only)

• Social Desirability (SDRS-5)

  baseline

• Predictor of Drop-out Questionnaire

  baseline

Study Arms (2)

Choice Group

PLACEBO COMPARATOR

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

Healthy Minds Program (HMP) Group

EXPERIMENTAL

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

Interventions

Healthy Minds Program Foundations Training BEHAVIORAL

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.

Choice Group; Healthy Minds Program (HMP) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Chan Zuckerberg Initiative: collaborator

Study Sites (1)

Jefferson County Public Schools

Louisville, Kentucky, 40218, United States

Location

Related Publications (18)

• 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.

  PMID: 21697139 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.

  BACKGROUND

• Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.

  BACKGROUND

• 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.

  PMID: 27182765 BACKGROUND

• 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.

  PMID: 22250775 BACKGROUND

• 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.

  PMID: 28904592 BACKGROUND

• 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.

  PMID: 32299304 BACKGROUND

• 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.

  PMID: 35174010 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34000843 BACKGROUND

• 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.

  PMID: 18310597 BACKGROUND

• 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.

  PMID: 23437856 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• 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.

  BACKGROUND

• International Wellbeing Group (2013). Personal Wellbeing Index: 5th Edition. Melbourne: Australian Centre on Quality of Life, Deakin University

  BACKGROUND

• 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.

  PMID: 33245288 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Matthew J Hirshberg

  UW-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and data analyst will not know condition assignment until after data analyses are complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random parallel assignment

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: October 21, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Study hypotheses and statistical analysis plans will be preregistered prior to enrollment and made publicly available at the time of relevant manuscript submissions. Analytic code will be made available following manuscript publication. De-identified study data will be made publicly available following manuscript publication. All public information will be accessible for an indefinite period of time.
• Access Criteria: No access criteria

Locations

US (1)