AnxietyNCT05561933
Scaling Well-Being for Educators During COVID-19
A study testing Healthy Minds Program Foundations Training in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Healthy Minds Program Foundations Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 829 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson County Public Schools
Louisville, Kentucky, 40218
About this study
Official title: COVID-19 and the Healthy Minds Program for Educators II
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Healthy Minds Program Foundations Training
- Keywords
- Well-being
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds Program Foundations TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Minds Program Foundations Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start21 Oct 2022
- Primary completion30 Jul 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random parallel assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Chan Zuckerberg Initiative
- Responsible party
- Sponsor
- Investigators
- Matthew J Hirshberg, Principal investigator, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561933
- Sponsor's protocol ID
- 2022-0313
- Other IDs
- IRB Approval Date: 08/16/2022, A483000
- Status last verified
- May 2025
- First submitted
- 27 Sep 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Prespecified hypotheses and analyses plans will be preregistered on osf.io prior to recruitment. De-identified study data will be posted on osf.io after publication of trial analyses. Code used in all publications will be available by request.
Publications
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.
PubMed 21697139Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.
Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.
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.
PubMed 27182765Yu 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.
PubMed 22250775Pepe 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.
PubMed 28904592Lee 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.
PubMed 32299304Britton 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.
PubMed 35174010Brose, 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
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.
PubMed 34000843Baer 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.
PubMed 18310597Cyranowski 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.
PubMed 23437856Devilly 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.
PubMed 11132119Hays, 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and the Healthy Minds Program for Educators II
- ClinicalTrials.gov ID
- NCT05561933
- Acronym / sponsor ID
- 2022-0313
- Conditions
- Anxiety, Depression
- Keywords
- Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Chan Zuckerberg Initiative
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Random parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Choice Group | Placebo comparator | Behavioral: Healthy Minds Program Foundations TrainingParticipants 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. |
| Healthy Minds Program (HMP) Group | Experimental | Behavioral: Healthy Minds Program Foundations TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Individuals under 18 years old
- Significant meditation experience:
- PROMIS depression score greater than 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Minds Program Foundations TrainingThe 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. | Behavioural | Choice Group, Healthy Minds Program (HMP) Group |
Primary outcome
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.
17 secondary outcomes
Well-being (WHO-5)
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Change From Baseline on the Perseverative Thought Questionnaire
Time frame: baseline, 4 weeks (post intervention)
Change From Baseline on the Growth Mindset Scale for Well-Being
Time frame: baseline, after weeks 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Change from Baseline in Healthy Minds Index
Time frame: baseline, after week 2, 4 weeks (post intervention)
Change from Baseline in Perceived Stress Scale
Time frame: 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
Time frame: 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)
Time frame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Change in Baseline in Rumination About Work at Home Survey
Time frame: 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)
Time frame: baseline, week 4 (post intervention), 20 weeks (5 months post-intervention)
Change in Baseline in Personal Wellbeing Index (PWI)
Time frame: baseline, week 4 (post intervention), 20 weeks (5 months post-intervention)
Change in Baseline in Sleep Quality
Time frame: baseline, after weeks 1 and 2, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Persistence in the profession
Time frame: 12-18 months after baseline
Change from baseline on reflection rings / circles
Time frame: 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
Time frame: baseline, 4 weeks (post intervention), 20 weeks (5 months post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 21697139Pilkonis 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundBech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.
- BackgroundMaslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.
- Background: PubMed 27182765Crain 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.
- Background: PubMed 22250775Yu 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.
- Background: PubMed 28904592Pepe 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.
- Background: PubMed 32299304Lee 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.
- Background: PubMed 35174010Britton 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.
- BackgroundBrose, 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: PubMed 34000843Goldberg 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.
- Background: PubMed 18310597Baer 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.
- Individual participant dataSharing planned: Yes. Prespecified hypotheses and analyses plans will be preregistered on osf.io prior to recruitment. De-identified study data will be posted on osf.io after publication of trial analyses. Code used in all publications will be available by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Hirshberg principal investigator
UW-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program Foundations Training in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 20 weeks (5 months post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561933, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.